Pulmonary-Allergy Drugs Advisory Committee Meeting

Pulmonary-Allergy Drugs Advisory Committee Meeting Committee Meeting : March 7, 2013 from 8:00 a.m. to 5:00 p.m. Agenda: The committee will discuss the new drug application (NDA) 204275 for fluticasone furoate and vilanterol dry powder inhaler (proposed tradename BREO ELLIPTA), sponsored by GlaxoSmithKline, for the long-term maintenance treatment of airflow obstruction and for reducing exacerbations in patients with chronic obstructive pulmonary disease.

Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee

Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Committee Meeting April 5, 2013 8:00 a.m. - 6:00 p.m. Agenda: On April 5, 2013, the committee will discuss and make recommendations regarding the possible reclassification of Shortwave Diathermy devices. On July 6, 2012 (77 FR 39953), FDA issued a proposed rule which, if made final, would make Shortwave Diathermy devices Class III, requiring premarket approval. In response to the proposed rule, FDA received petitions under section 515(b)(2)(B) of the Federal Food, Drug, and Cosmetic Act requesting a change in classification. The reclassification petitions are available for public review and comment at www.regulations.gov under docket number FDA-2012-N-0378.

Neurological Devices Panel of the Medical Devices Advisory Committee

Neurological Devices Panel of the Medical Devices Advisory Committee Committee Meeting February 22, 2013 8:00 a.m. - 6:00 p.m. Agenda: On February 22, 2013, the committee will discuss, make recommendations and vote on information regarding the premarket approval application (PMA) for the NeuroPace RNS System sponsored by NeuroPace, Inc. The RNS System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in individuals 18 years of age or older with partial onset seizures from no more than two foci that are refractory to two or more antiepileptic medications.

Pulmonary-Allergy Drugs Advisory Committee Meeting

Pulmonary-Allergy Drugs Advisory Committee Meeting Committee Meeting January 30, 2013 8:00 a.m. to 4:00 p.m. (Day 2 of 2) Agenda: The committee will discuss the new drug application (NDA) 202049, for mannitol inhalation powder (proposed trade name BRONCHITOL), for oral inhalation sponsored by Pharmaxis, for the proposed indication of management of cystic fibrosis (CF) in patients aged 6 years and older to improve pulmonary function.

Pulmonary-Allergy Drugs Advisory Committee Meeting

Pulmonary-Allergy Drugs Advisory Committee Meeting Committee Meeting on January 29, 2013 8:00 a.m. to 5:00 p.m. (Day 1 of 2) Agenda: The committee will discuss the new drug application (NDA) 203108, for olodaterol (proposed trade name Striverdi Respimat) metered dose inhaler, sponsored by Boehringer Ingelheim, for the proposed indication of long-term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

Endocrinologic and Metabolic Drugs Advisory Committee

Endocrinologic and Metabolic Drugs Advisory Committee Committee Meeting January 10, 2013 8:00 a.m. to 5:00 p.m. Agenda: The committee will discuss new drug application (NDA) 204042, canagliflozin tablets, proposed trade name INVOKANA, submitted by Janssen Research and Development, LLC. Canagliflozin is a member of the sodium-glucose co-transporter 2 (SGLT2) inhibitors, and was developed as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Arthritis Advisory Committee

Arthritis Advisory Committee Committee Meeting December 20, 2012, from 8 a.m. to 5 p.m. Agenda: The committee will discuss new drug application (NDA) 22151, rintatolimod injection (proposed trade name AMPLIGEN), submitted by Hemispherx Biopharma, Inc., for the treatment of patients with chronic fatigue syndrome.

Meeting of the Drug Safety and Risk Management Advisory Committee

Meeting of the Drug Safety and Risk Management Advisory Committee Committee Meeting December 13, 2012 8:00 a.m. to 3:30 p.m. (Day 2 of 2) On December 13, 2012 the committee will discuss two common risk management tools used to minimize the risk of teratogens – contraception and pregnancy testing. The committee will discuss considerations for standardizing recommendations for use of these two tools.

Meeting of the Drug Safety and Risk Management Advisory Committee

Meeting of the Drug Safety and Risk Management Advisory Committee Committee Meeting : December 12, 2012 8:00 a.m. to 5:30 p.m. (Day 1 of 2) The Food and Drug Administration Amendments Act of 2007 requires FDA to bring, at least annually, one or more drugs with Risk Evaluation and Mitigation Strategies (REMS) with Elements to Assure Safe Use (ETASU) before CDER's Drug Safety and Risk Management Advisory Committee (DSaRM). The Agency plans to present information on the risk management of teratogens, some of which have REMS with ETASU. On December 12, 2012, the DSaRM advisory committee will meet to discuss the various strategies used by the Agency to define and address teratogenic risk, including requiring REMS with ETASU. The discussion will include an evaluation of the different strategies and the decision framework for selecting risk management strategies for teratogens. The committee will discuss whether the risk management strategies, including REMS with ETASU, assure safe use, are not unduly burdensome to patient access to the drug, and to the extent practicable, minimize the burden to the health care delivery system.

Neurological Devices Panel of the Medical Devices Advisory Committee

Neurological Devices Panel of the Medical Devices Advisory Committee Committee Meeting December 10, 2012 8:00 a.m. - 5:00 p.m. Agenda: On December 10, 2012, the committee will discuss current knowledge about the safety and effectiveness of the CoAxia NeuroFlo Catheter device for the intended use of diverting cardiac output to the cerebral vasculature via partial occlusion of the descending aorta, including in patients with acute ischemic stroke within 14 hours of symptom onset. The CoAxia NeuroFlo Catheter is a 7F multi-lumen device with two balloons mounted near the distal tip. The proximal end has a multi-port manifold which provides access for the guidewire, monitoring of blood pressure, and independent inflation of the individual balloons. The device is placed in the descending aorta. On March 30, 2005, a Humanitarian Device Exemption application for the CoAxia NeuroFlo Catheter was approved for the following indication for use: The CoAxia NeuroFlo Catheter is intended for the treatment of cerebral ischemia resulting from symptomatic vasospasm following aneurismal subarachnoid hemorrhage (SAH), secured by either surgical or endovascular intervention for patients who have failed maximal medical management. Of note, the CoAxia Neuroflo Catheter is identical in design to the Coaxia FloControl which is currently cleared for the following general indications for use: The CoAxia FloControl Catheter is intended for use in selectively stopping or controlling flow in the peripheral vasculature (K023914). The CoAxia FloControl Catheter is intended for use in selectively stopping or controlling flow in the peripheral vasculature, which includes the descending aorta (K090970). CoAxia has submitted a de novo application for the NeuroFlo Catheter for the following indication: The CoAxia NeuroFlo Catheter is intended for use in diversion of cardiac output via partial occlusion of the descending aorta, including patients with acute ischemic stroke within 14 hours of symptom onset. The CoAxia NeuroFlo Catheter is also intended for use in selectively stopping or controlling blood flow in the peripheral vasculature, which includes the descending aorta. FDA is convening this committee to seek expert scientific and clinical opinion on the risks and benefits of this device based on the available premarket and postmarket data. In particular, the panel will be asked to discuss the safety and effectiveness data from the “Safety and Efficacy of NeuroFlo Technology in Ischemic Stroke (SENTIS)” clinical trial as they relate to the proposed indications for use.

Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee

Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee Committee Meeting : December 7, 2012 8:00 a.m. to 5:00 p.m. Agenda: The committee will discuss the risks and benefits of new drug application (NDA) 202880, by Zogenix Inc., for hydrocodone bitartrate extended-release capsules (proposed trade name Zohydro ER), an opioid analgesic medication for the management of moderate to severe chronic pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. This formulation of hydrocodone bitartrate extended-release capsules represents the first single-entity (i.e., containing no other active pharmaceutical ingredients, such as acetaminophen or ibuprofen) hydrocodone-containing drug product. It will be formulated in dose strengths up to 50 mg, and administered twice daily (i.e., every 12 hours). The committee will be asked to determine whether the benefit-risk assessment of this product favors its approval for marketing

Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting

Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting Committee Meeting : December 5-6, 2012 8:00 a.m. - 6:00 p.m. (Day 2 of 2) Agenda: On December 6, 2012, the committee will discuss and make recommendations regarding the 515(i) order issued by FDA on April 9, 2009 [Docket No. FDA-2009-M-0101], for Nonroller-type cardiopulmonary bypass blood pumps, one of the remaining pre-Amendment Class III devices. A nonroller-type cardiopulmonary bypass blood pump is a device that uses a method other than revolving rollers to pump blood. There are two types of nonroller-type pumps which have been reviewed by the Agency: 1) Centrifugal type pumps utilize a rotor to impart energy to the blood in an extracorporeal circuit through centrifugal forces. These pumps are part of an extracorporeal circuit usually containing an oxygenator and are intended to provide cardiopulmonary support, during procedures such as cardiopulmonary bypass surgery, for periods lasting 6 hours or less. 2) Micro-axial type pumps are comprised of a pump motor, a cannula and a catheter that connects to a console. These pumps are not designed to be used with an oxygenator but are temporarily placed within the heart or vasculature to provide cardiac support only.

Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting

Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting Committee Meeting : December 5, 2012 8:00 a.m. - 6:00 p.m. (Day 1 of 2) Agenda: On December 5, 2012, during session I, the committee will discuss and make recommendations regarding the 515(i) order issued by FDA on April 9, 2009 [Docket No. FDA-2009-M-0101], for the external counter-pulsating (ECP) devices, one of the remaining pre-Amendment Class III devices. These systems typically consist of a treatment table, pressure cuffs and a controller. They are intended to provide noninvasive circulatory support by applying external pressure to the lower extremities during diastole to increase coronary perfusion pressure, and releasing external pressure during systole to reduce left ventricular workload.

Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee

Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee Committee Meeting December 4, 2012 8:00 a.m. to 5:30 p.m. Agenda: The subcommittee will receive a presentation on pediatric provisions mandated by the Food and Drug Administration Safety and Innovation Act. This will be an awareness presentation and there will not be a formal Committee discussion or recommendation. In addition, information will be presented regarding pediatric development plans for four products that are in development for an adult oncology indication. The subcommittee will consider and discuss issues relating to the development of each product for pediatric use and provide guidance to facilitate the formulation of written requests for pediatric studies, if appropriate. The four products under consideration are: (1) Trametinib, application submitted by GlaxoSmithKline, LLC; (2) TH-302, application submitted by Threshold Pharmaceuticals, Inc.; (3) volasertib (BI 6727), application submitted by Boehringer Ingelheim Pharmaceuticals, Inc.; and (4) blinatumomab (MT 103), application submitted by Amgen Inc.

Anti-Infective Drugs Advisory Committee Meeting

Anti-Infective Drugs Advisory Committee Meeting Committee Meeting November 29, 2012 8:00 a.m. to 5:00 p.m. (Day 2 of 2) Agenda: On November 29, 2012, the committee will discuss new drug application (NDA) 22407, VIBATIV (telavancin hydrochloride) sterile powder for injection, submitted by Theravance, Inc., for the requested indication of nosocomial pneumonia (pneumonia contracted by hospitalized patients), including ventilator-associated pneumonia (VAP), caused by susceptible isolates of the following Gram-positive bacteria: Staphylococcus aureus (including methicillin-susceptible and –resistant isoloates) or Streptococcus pneumoniae (penicillin susceptible strains).

Anti-Infective Drugs Advisory Committee

Anti-Infective Drugs Advisory Committee Committee Meeting November 28, 2012 8:00 a.m. to 5:00 p.m. (Day 1 of 2) Agenda: On November 28, 2012, the committee will discuss the safety and effectiveness of new drug application (NDA) 204384, bedaquiline tablets, submitted by Janssen Therapeutics, Division of Janssen Products, LP. The proposed indication (use) for this product is for the treatment of patients with multi-drug resistant pulmonary tuberculosis.

Anti-Infective Drugs Advisory Committee

Anti-Infective Drugs Advisory Committee Committee Meeting November 29, 2012 8:00 a.m. to 5:00 p.m. Agenda: On November 29, 2012, the committee will discuss new drug application (NDA) 22407, VIBATIV (telavancin hydrochloride) sterile powder for injection, submitted by Theravance, Inc., for the requested indication of nosocomial pneumonia (pneumonia contracted by hospitalized patients), including ventilator-associated pneumonia (VAP), caused by susceptible isolates of the following Gram-positive bacteria: Staphylococcus aureus (including methicillin-susceptible and –resistant isoloates) or Streptococcus pneumoniae (penicillin susceptible strains).

Oncologic Drugs Advisory Committee Meeting

Oncologic Drugs Advisory Committee Meeting Committee Meeting November 8, 2012 8:00 a.m. to 5:00 p.m Agenda: During the morning session, the committee will discuss new drug application (NDA) 204026, with the established name pomalidomide, application submitted by Celgene Corporation. The proposed indication (use) for this product is in combination with dexamethasone for patients with relapsed and refractory multiple myeloma who have received at least 2 prior regimens of established benefit, including both lenalidomide and bortezomib and have demonstrated disease progression on the last therapy. During the afternoon session, the committee will discuss supplemental New Drug Application (sNDA) 021882/015, with the trade name Exjade (deferasirox) tablets for oral suspension, application submitted by Novartis Pharmaceutical Corporation. The proposed indication (use) for this product is for the treatment of chronic iron overload in patients with non-transfusion-dependent thalassemia syndromes (beta-thalassemia intermedia, HbE beta-thalassemia, and alpha-thalassemia) aged 10 years and older.

Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee

Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee Committee Meeting December 4, 2012 8:00 a.m. to 5:30 p.m. Agenda: The subcommittee will receive a presentation on pediatric provisions mandated by the Food and Drug Administration Safety and Innovation Act. This will be an awareness presentation and there will not be a formal Committee discussion or recommendation. In addition, information will be presented regarding pediatric development plans for four products that are in development for an adult oncology indication. The subcommittee will consider and discuss issues relating to the development of each product for pediatric use and provide guidance to facilitate the formulation of written requests for pediatric studies, if appropriate. The four products under consideration are: (1) Trametinib, application submitted by GlaxoSmithKline, LLC; (2) TH-302, application submitted by Threshold Pharmaceuticals, Inc.; (3) volasertib (BI 6727), application submitted by Boehringer Ingelheim Pharmaceuticals, Inc.; and (4) blinatumomab (MT 103), application submitted by Amgen Inc.

Nonprescription Drugs Advisory Committee Meeting

Nonprescription Drugs Advisory Committee Meeting
Committee Meeting November 9, 2012 8:00 a.m. to 5:00 p.m.

Agenda: On November 9, 2012, the committee will discuss data submitted by MSD Consumer Care, Inc. to support new drug application (NDA) 202211, for the partial switch from prescription to over-the-counter (OTC) of the oxybutynin transdermal system (proposed trade name OXYTROL FOR WOMEN). The proposed OTC use is "treats overactive bladder in women." The data to be discussed will include a summary of the postmarketing experience with the oxybutynin transdermal system, and the results of consumer studies, including label comprehension studies, self-selection studies, and an actual use study. The committee will be asked to consider whether the data support the appropriate and safe use of oxybutynin transdermal system by OTC consumers.

Anti-Infective Drugs Advisory Committee

Anti-Infective Drugs Advisory Committee
Committee Meeting November 2, 2012 8:00 a.m. to 5:00 p.m.

Agenda: On November 2, 2012, the committee will discuss biologics licensing application (BLA) 125346, raxibacumab injection, a humanized monoclonal antibody against protective antigen of Bacillis anthracis, by Human Genome Sciences, Inc. for the proposed indication of treatment of inhalational anthrax.

Radiological Devices Panel of the Medical Devices Advisory Committee

Radiological Devices Panel of the Medical Devices Advisory Committee
Committee Meeting on October 24, 2012, from 8 a.m. to 5:00 p.m.

Agenda: On October 24, 2012, the committee will discuss, make recommendations, and vote on a premarket approval application supplement to expand the indications for use of the Selenia Dimensions 3D System with C-View Software Module, sponsored by Hologic, Inc. The Selenia Dimensions 3D System is currently approved for breast cancer screening and diagnosis. The screening exam can consist of field digital mammography (FFDM) alone or the combination of FFDM with digital breast tomosynthesis (DBT). The new C-View Software Module can generate synthetic 2D images from the DBT data. Hologic requests to expand the indications for use to allow the combination of DBT with synthetic 2D images to be used as another exam option for breast cancer screening.

Endocrinologic and Metabolic Drugs Advisory Committee

Committee Meeting October 18, 2012, from 8 a.m. to 5p.m. (Day 2 of 2)

Agenda: The committee will discuss new drug application (NDA) 203568, mipomersen injection, by Genzyme Corporation. The proposed indication (use) is as an adjunct to maximally tolerated lipid-lowering medications and diet to reduce low-density lipoprotein (LDL) cholesterol, apolipoprotein B, total cholesterol, non-high density lipoprotein-cholesterol and lipoprotein (a) in patients with homozygous familial hypercholesterolemia.

Endocrinologic and Metabolic Drugs Advisory Committee

Endocrinologic and Metabolic Drugs Advisory Committee
Committee Meeting October 17, 2012, from 8 a.m. to 5 p.m. (Day 1 of 2)

Agenda: The committee will discuss new drug application (NDA) 203858, lomitapide capsules, by Aegerion Pharmaceuticals, Inc. The proposed indication (use) is as an adjunct to a low-fat diet and other lipid-lowering drugs with or without low-density lipoprotein (LDL) apheresis to reduce LDL cholesterol, total cholesterol, apolipoprotein B, and triglycerides in patients with homozygous familial hypercholesterolemia. (Apheresis is a laboratory technology used to remove LDL from the bloodstream.)

FDAAC.Com Live Webcast (Humira) - Gastrointestinal Drugs Advisory Committee Meeting

Gastrointestinal Drugs Advisory Committee
Committee Meeting October 16, 2012, from 8 a.m. to 5 p.m. (Day 2 of 2)

Agenda: The Committee will discuss the safety and efficacy of new drug application (NDA) 203441, with the proposed trade name GATTEX (teduglutide) for subcutaneous injection, by NPS Pharmaceuticals, Inc, for the proposed indication of treatment of adult patients with short bowel syndrome (SBS).

Gastrointestinal Drugs Advisory Committee

Gastrointestinal Drugs Advisory Committee Committee Meeting October 15, 2012, from 8 a.m. to 5 p.m. (Day 1 of 2) Agenda: The committee will provide advice and recommendations to the Agency on the need for and design of clinical development programs necessary to support approval of parenteral lipid emulsion products as nutritional support.

Blood Products Advisory Committee

Blood Products Advisory Committee Committee Meeting September 21 from 8:00 a.m. to approximately 4:00 p.m. (Day 2 of 2) Agenda: On September 21, 2012, the committee will discuss considerations for strategies to further reduce the risk of bacterial contamination in Platelets. In the late afternoon the committee will hear the following update: summary of September 6-7, 2012 public workshop on the risks and benefits of hydroxyethyl starch solutions.

Blood Products Advisory Committee

Blood Products Advisory Committee Committee Meeting September 20 from 8:00 a.m. to 5:00 p.m. (Day 1 of 2) Agenda: On September 20, 2012, the committee will discuss hepatitis E virus and blood transfusion safety. In the afternoon, the committee will discuss Octapharma’s biologics license application for Pooled Plasma (Human, Solvent/Detergent Treated).

Cardiovascular and Renal Drugs Advisory Committee

Cardiovascular and Renal Drugs Advisory Committee Committee Meeting September 13, 2012 8:00 a.m. to 5:00 p.m. (Day 1 of 2) Agenda: During the morning session, the committee will discuss new drug application (NDA) 203009, lixivaptan, submitted by Cardiokine Biopharma, LLC, for the proposed indication of the treatment of symptomatic hypervolemic and euvolemic hyponatremia associated with heart failure and syndrome of inappropriate antidiuretic hormone (SIADH), respectively. During the afternoon session, the committee will discuss NDA 203826, phenylephrine hydrochloride injection, USP, submitted by West-Ward Pharmaceutical Corp., to increase blood pressure in acute hypotensive states, such as shock and peri-operative hypotension.

Pediatric Advisory Committee Meeting

Pediatric Advisory Committee Meeting Committee Meeting September 11, 2012 8:30 a.m. – 4:00 p.m. Agenda: On Tuesday, September 11, 2012, the Pediatric Advisory Committee will meet to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act, for Kapvay (clonidine hydrochloride), Vyvanse (lisdexamfetamine dimesylate), Ofirmev (acetaminophen), ella (ulipristal acetate), Beyaz (drospirenone/ethinyl estradiol/levomefolate calcium tablets and levomefolate calcium tablets), LoLoestrin Fe (norethindrone acetate and ethinyl estradiol ethinyl estradiol and ferrous fumarate), Aridol (mannitol inhalation powder), Augmentin XR (amoxicillin/clavulanate potassium), Afinitor (everolimus), Moxeza (moxifloxacin hydrochloride), and Lastacaft (alcaftadine).

Meeting of the Drug Safety and Risk Management Advisory Committee

Meeting of the Drug Safety and Risk Management Advisory Committee Committee Meeting October 29, 2012 from 8:00 a.m. to 5:00 p.m. (Day 2 of 2) Agenda: On October 29 and 30, 2012, the committee will discuss the public health benefits and risks, including the potential for abuse, of drugs containing hydrocodone either combined with other analgesics or as an antitussive. The Department of Health and Human Services received a request from the Drug Enforcement Administration for a scientific and medical evaluation and scheduling recommendation for these products in response to continued reports of misuse, abuse, and addiction related to these products.

Meeting of the Drug Safety and Risk Management Advisory Committee

Meeting of the Drug Safety and Risk Management Advisory Committee Committee Meeting October 29, 2012 from 8:00 a.m. to 5:00 p.m. (Day 1 of 2) Agenda: On October 29 and 30, 2012, the committee will discuss the public health benefits and risks, including the potential for abuse, of drugs containing hydrocodone either combined with other analgesics or as an antitussive. The Department of Health and Human Services received a request from the Drug Enforcement Administration for a scientific and medical evaluation and scheduling recommendation for these products in response to continued reports of misuse, abuse, and addiction related to these products.

Ophthalmic Devices Panel of the Medical Devices Advisory Committee

Ophthalmic Devices Panel of the Medical Devices Advisory Committee Committee Meeting September 28, 2012 8:00 a.m. - 6:00 p.m. Agenda: On September 28, 2012, the committee will discuss, make recommendations and vote on information regarding the humanitarian device exemption (HDE) application for the Argus II Retinal Prosthesis System sponsored by Second Sight Medical Products, Inc. The proposed Indication for Use for the Argus II (as stated in the HDE) is as follows: The Argus II System is indicated for use in patients with severe to profound retinitis pigmentosa who meet the following criteria: • Adults, age 25 years or older. • Bare light or no light perception in both eyes with Snellen acuity worse than 20/2100 or 2.1 logMAR. If the patient has no residual light perception, the retina must be able to respond to electrical stimulation as evidenced by an electrically evoked response. • Previous history of useful form vision.

Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee

Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Committee Meeting September 21, 2012 8:00 a.m. - 6:00 p.m. Agenda: On September 21, 2012, the committee will discuss and make recommendations regarding the classification of posterior cervical screws, including pedicle and lateral mass screws. Cervical pedicle and lateral mass screws are components of rigid, posterior spinal screw and rod systems generally intended as an adjunct to fusion for the treatment of degenerative disc disease (as defined by neck pain confirmed by radiographic studies), trauma, deformity, failed previous fusion, tumor, infection, and inflammatory disorders in the cervical spine.

Vaccines and Related Biological Products Advisory Committee Meeting

Vaccines and Related Biological Products Advisory Committee Meeting Committee Meeting September 19, 2012 between approximately 8:00 a.m. and 4:00 p.m. Agenda: On September 19, 2012, the committee will meet in open session to discuss consideration of the appropriateness of cell lines derived from human tumors for vaccine manufacture.

Cardiovascular and Renal Drugs Advisory Committee Meeting

Cardiovascular and Renal Drugs Advisory Committee Meeting Committee Meeting September 14, 2012 8:00 a.m. to 5:00 p.m. Agenda: The committee will discuss new drug application (NDA) 203446, imatinib mesylate, submitted by Novartis Pharmaceuticals Corp., as adjunctive therapy for the treatment of pulmonary arterial hypertension (WHO Diagnostic Group 1), to improve exercise capacity and cardio-pulmonary hemodynamics in patients who remain symptomatic despite treatment with two or more approved vasodilator therapies (“vasodilator therapies” refer to medicines used to dilate blood vessels and thereby reduce resistance to blood flow).

Anti-Infective Drugs Advisory Committee

Anti-Infective Drugs Advisory Committee Committee Meeting September 5, 2012 8:00 a.m. to 5:00 p.m. Agenda: The committee will discuss new drug application (NDA) 201688, tobramycin inhalation powder, application submitted by Novartis Pharmaceuticals Corporation, and the requested indication of management of cystic fibrosis patients infected with the bacterium Pseudomonas aeruginosa.

Advisory Committee for Pharmaceutical Science and Clinical Pharmacology

Advisory Committee for Pharmaceutical Science and Clinical Pharmacology [Committee Meeting August 9, 2012 8:00 a.m. to 5:00 p.m. (Day 2 of 2) Agenda: During the morning session, the committee will discuss FDA''s draft guidance on tablet scoring. This topic will include an overview of FDA''s proposed plan to move forward and the United States Pharmacopoeia’s (USP) perspective on the topic. During the afternoon session, the committee will discuss: (1) the Center for Drug Evaluation and Research (CDER) Nanotechnology Risk Management Working Group activities; (2) nanotechnology-related research conducted and published by CDER, to include examples related to sunscreens; and (3) the overview and preliminary analysis of nanotechnology-related information collected from drug application submissions.

Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting, [Committee Meeting August 8, 2012 8:00 a.m. to 5:00 p.m. (Day 1 of 2)] Add To Cart 140.00 Agenda: During the first session, the committee will discuss the uses and limitations of in vitro dissolution testing and propose future direction for evaluation including possible research. During the second session, the committee will receive an update on the FDA’s recently posted draft guidances for industry on biosimilar products. This will be an awareness topic and there will not be formal Committee discussion or recommendation.

Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting

Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting [Committee Meeting August 8, 2012 8:00 a.m. to 5:00 p.m. (Day 1 of 2)] Agenda: During the first session, the committee will discuss the uses and limitations of in vitro dissolution testing and propose future direction for evaluation including possible research. During the second session, the committee will receive an update on the FDA’s recently posted draft guidances for industry on biosimilar products. This will be an awareness topic and there will not be formal Committee discussion or recommendation.

Gastrointestinal Drugs Advisory Committee Meeting

Gastrointestinal Drugs Advisory Committee Meeting
Committee Meeting August 28, 2012 8:00 a.m. to 5:00 p.m.

Agenda: The committee will discuss the results from clinical trials of supplemental biologics license application (sBLA) 125057/232, for Humira (adalimumab), by Abbott Laboratories, for the proposed indication (use) for reducing signs and symptoms, and achieving clinical remission in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy.

Dermatologic and Ophthalmic Drugs Advisory Committee

Dermatologic and Ophthalmic Drugs Advisory Committee
Committee Meeting July 26, 2012 8:00 a.m. to 5:00 p.m.

Agenda: During the morning session, the committee will discuss a supplement to biologics license application (BLA) 125156 for LUCENTIS (ranibizumab) injection by Genentech, Inc., for the treatment of diabetic macular edema (DME). Ranibizumab injection is currently approved for the treatment of neovascular (wet) age-related macular degeneration (AMD) and macular edema following retinal vein occlusion (RVO).

During the afternoon session, the committee will discuss new biologics license application (BLA) 125422, ocriplasmin intravitreal injection (proposed tradename, Jetrea) by ThromboGenics, Inc., indicated for the treatment of symptomatic vitreomacular adhesions (sVMA) including macular hole.

Oncologic Drugs Advisory Committee Meeting

Oncologic Drugs Advisory Committee Meeting
Committee Meeting July 25, 2012 8:00 a.m. to 12:30 p.m (Day 2 of 2)

Agenda: The committee will discuss and provide general advice on the extent to which, if any, the pre-surgical identification of clear cell carcinoma of the kidney using an imaging test provides useful clinical information.

Oncologic Drugs Advisory Committee Meeting

Oncologic Drugs Advisory Committee Meeting
Committee Meeting : July 24, 2012 8:00 a.m. to 5:00 p.m. (Day 1 of 2)

Agenda: During the morning session, the committee will discuss supplemental new drug application (sNDA) 022059/014 with the trade name Tykerb (lapatinib) tablets, application submitted by SmithKline Beecham (Cork) Ltd, Ireland d/b/a GlaxoSmithKline. The proposed indication (use) for this product is in combination with trastuzumab for the treatment of patients with metastatic breast cancer whose tumors overexpress HER2 and who have received prior trastuzumab therapy(s).

During the afternoon session, the committee will discuss the evaluation of radiographic review in randomized clinical trials using progression-free survival (PFS) as a primary endpoint in non-hematologic malignancies. They will consider the merits of an independent audit of investigator progression assessment in a pre-specified subgroup of patients instead of an independent review of all progression assessments. The expectation is that an independent audit would streamline the conduct of clinical trials, as well as avoid missing data when no additional protocol specified progression assessments are mandated. Hematologic malignancies are excluded from this discussion because other issues (e.g., blood counts, lymph node exams, and other biomarkers) influence the assessment of PFS.

Oncologic Drugs Advisory Committee Meeting

Oncologic Drugs Advisory Committee Meeting
Committee Meeting July 25, 2012 8:00 a.m. to 12:30 p.m (Day 2 of 2)

Agenda: The committee will discuss and provide general advice on the extent to which, if any, the pre-surgical identification of clear cell carcinoma of the kidney using an imaging test provides useful clinical information.

Oncologic Drugs Advisory Committee Meeting

Oncologic Drugs Advisory Committee Meeting
Committee Meeting : July 24, 2012 8:00 a.m. to 5:00 p.m. (Day 1 of 2)

Agenda: During the morning session, the committee will discuss supplemental new drug application (sNDA) 022059/014 with the trade name Tykerb (lapatinib) tablets, application submitted by SmithKline Beecham (Cork) Ltd, Ireland d/b/a GlaxoSmithKline. The proposed indication (use) for this product is in combination with trastuzumab for the treatment of patients with metastatic breast cancer whose tumors overexpress HER2 and who have received prior trastuzumab therapy(s).

During the afternoon session, the committee will discuss the evaluation of radiographic review in randomized clinical trials using progression-free survival (PFS) as a primary endpoint in non-hematologic malignancies. They will consider the merits of an independent audit of investigator progression assessment in a pre-specified subgroup of patients instead of an independent review of all progression assessments. The expectation is that an independent audit would streamline the conduct of clinical trials, as well as avoid missing data when no additional protocol specified progression assessments are mandated. Hematologic malignancies are excluded from this discussion because other issues (e.g., blood counts, lymph node exams, and other biomarkers) influence the assessment of PFS.

Risk Communication Advisory Committee

Risk Communication Advisory Committee
Committee Meeting June 29, 2012 8:00 a.m. - 3:00 p.m.

Agenda: On June 29, 2012, the Committee will discuss recent research on communicating and understanding uncertainty, and risk perception and information seeking when facing multiple risks.

Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee

Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee

Committee Meeting June 27th 2012 8:00 a.m. - 7:00 p.m.(Day 2 of 2)

Agenda: On June 27 and 28, 2012, the committee will discuss current knowledge about the safety and effectiveness of Metal-on-Metal (MoM) hip arthroplasty systems. FDA is convening this committee to seek expert scientific and clinical opinion on the risks and benefits of these types of devices based on available scientific data.

Hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.

There are two categories of metal-on-metal hip arthroplasty systems:

1. Metal-on-Metal total hip replacement (THR) systems consist of a metal ball (femoral head), a metal femoral stem in the thighbone, and a metal cup in the hip bone (acetabular component). MoM THR systems are typically indicated for use in total hip arthroplasty in skeletally mature patients with the following conditions:
a. Non-inflammatory degenerative joint disease (NIDJD) such as osteoarthritis, avascular necrosis, post-traumatic arthritis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
b. Inflammatory degenerative joint disease such as rheumatoid arthritis;
c. Correction of functional deformity; and,
d. Revision procedures where other treatments or devices have failed.

2. Metal-on-Metal hip resurfacing systems consist of a trimmed femoral head capped with a metal covering and a metal cup in the hip bone (acetabular component). Hip resurfacing arthroplasty is intended for reduction or relief of pain and/or improved hip function in skeletally mature patients having the following conditions:
a. Non-inflammatory degenerative arthritis such as osteoarthritis, traumatic arthritis, avascular necrosis, or dysplasia/developmental dislocation of the hip (DDH); or
b. Inflammatory arthritis such as rheumatoid arthritis.

Resurfacing systems are intended for patients who, due to their relatively younger age or increased activity level, may not be suitable for traditional total hip arthroplasty due to an increased possibility of requiring ipsilateral hip joint revision.

Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee

Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee

Committee Meeting June 27th 2012 8:00 a.m. - 7:00 p.m.(Day 1 of 2)

Agenda: On June 27 and 28, 2012, the committee will discuss current knowledge about the safety and effectiveness of Metal-on-Metal (MoM) hip arthroplasty systems. FDA is convening this committee to seek expert scientific and clinical opinion on the risks and benefits of these types of devices based on available scientific data.

Hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.

There are two categories of metal-on-metal hip arthroplasty systems:

1. Metal-on-Metal total hip replacement (THR) systems consist of a metal ball (femoral head), a metal femoral stem in the thighbone, and a metal cup in the hip bone (acetabular component). MoM THR systems are typically indicated for use in total hip arthroplasty in skeletally mature patients with the following conditions:
a. Non-inflammatory degenerative joint disease (NIDJD) such as osteoarthritis, avascular necrosis, post-traumatic arthritis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
b. Inflammatory degenerative joint disease such as rheumatoid arthritis;
c. Correction of functional deformity; and,
d. Revision procedures where other treatments or devices have failed.

2. Metal-on-Metal hip resurfacing systems consist of a trimmed femoral head capped with a metal covering and a metal cup in the hip bone (acetabular component). Hip resurfacing arthroplasty is intended for reduction or relief of pain and/or improved hip function in skeletally mature patients having the following conditions:
a. Non-inflammatory degenerative arthritis such as osteoarthritis, traumatic arthritis, avascular necrosis, or dysplasia/developmental dislocation of the hip (DDH); or
b. Inflammatory arthritis such as rheumatoid arthritis.

Resurfacing systems are intended for patients who, due to their relatively younger age or increased activity level, may not be suitable for traditional total hip arthroplasty due to an increased possibility of requiring ipsilateral hip joint revision.

General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee

General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee
Committee Meeting June 21, 2012 8:00 a.m. - 6:00 p.m.

Agenda: On June 21, 2012, the committee will discuss, make recommendations, and vote on information related to the premarket approval application, sponsored by Dune Medical Devices, Inc., for the MarginProbe System, that utilizes electromagnetic waves to characterize human tissue in real time and provides intraoperative information on the malignancy of the surface of the ex vivo lumpectomy specimen.

Oncologic Drugs Advisory Committee

Oncologic Drugs Advisory Committee
Committee Meeting June 20, 2012 8:00 a.m. to 5:00 p.m

Agenda: During the morning session, the committee will discuss New Drug Application (NDA) 203213, with the established name semuloparin sodium injection, application submitted by sanofi-aventis U.S. LLC. The proposed indication (use) for this product is for the prophylaxis of venous thromboembolism (VTE) in patients receiving chemotherapy for locally advanced or metastatic pancreatic or lung cancer or for locally advanced or metastatic solid tumors with a VTE risk score ≥ 3.

During the afternoon session, the committee will discuss New Drug Application (NDA) 202714, with the proposed trade name Kyprolis (carfilzomib) for injection, application submitted by Onyx Pharmaceuticals, Inc. The proposed indication (use) for this product is for the treatment of patients with relapsed and refractory (recurring and/or not responsive to other treatments) multiple myeloma who have received at least 2 prior lines of therapy that included a proteasome inhibitor and an immunomodulatory agent.

Circulatory System Devices Panel of the Medical Devices Advisory Committee

Circulatory System Devices Panel of the Medical Devices Advisory Committee
Committee Meeting June 13, 2012 8:00 a.m. - 6:00 p.m.

Agenda: On June 13, 2012, the committee will discuss, make recommendations and vote on information related to the premarket approval application for the Edwards SAPIEN Transcatheter Heart Valve sponsored by Edwards Lifesciences. The Edwards SAPIEN Transcatheter Heart Valve is indicated for use in patients with symptomatic severe aortic stenosis who have high operative risk.

The Edwards SAPIEN Transcatheter Heart Valve, model 9000TFX, sizes 23mm and 26mm and accessories implant system consists of the following:
• A heterologous (bovine) pericardium leaflet valve sutured within a stainless steel mesh frame, with a polyester skirt. It is offered in two sizes, a 23 mm and a 26 mm.
• The RetroFlex 3 Delivery System is used to advance the bioprosthesis through the RetroFlex sheath over a guidewire and to track the bioprosthesis over the aortic arch and for crossing and positioning in the native valve. The delivery system also comes with a sheath, introducer, loader, dilator, balloon (used to pre-dilate the native annulus) and a crimper.

General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee

General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee
Committee Meeting June 21, 2012 8:00 a.m. - 6:00 p.m.

Agenda: On June 21, 2012, the committee will discuss, make recommendations, and vote on information related to the premarket approval application, sponsored by Dune Medical Devices, Inc., for the MarginProbe System, that utilizes electromagnetic waves to characterize human tissue in real time and provides intraoperative information on the malignancy of the surface of the ex vivo lumpectomy specimen.

Peripheral and Central Nervous System Drugs Advisory Committee

Peripheral and Central Nervous System Drugs Advisory Committee
Committee Meeting May 24, 2012 8:30 a.m. to 5:00 p.m.

Agenda: On May 24, 2012, the committee will discuss new drug application (NDA) 202737 for tafamidis meglumine capsules, proposed trade name VYNDAQEL, submitted by FoldRx Pharmaceuticals, Inc. a subsidiary of Pfizer, Inc. The proposed indication is for the treatment of transthyretin (TTR) familial amyloid polyneuropathy.

Cardiovascular and Renal Drugs Advisory Committee

Cardiovascular and Renal Drugs Advisory Committee

Agenda :On May 23, 2012, the Committee will discuss supplemental new drug application (sNDA) 202439/S-002 XARELTO (rivaroxaban), submitted by Janssen Pharmaceuticals, Inc. to reduce the risk of thrombotic cardiovascular events in patients with acute coronary syndrome (ACS) [ST elevation myocardial infarction (STEMI), non-ST elevation myocardial infarction (NSTEMI), or unstable angina (UA)] in combination with aspirin alone or with aspirin plus clopidogrel or ticlopidine.

Blood Products Advisory Committee

Blood Products Advisory Committee
Committee Meeting May 16 from 8:00 a.m. to approximately 4:00 p.m. (Day 2 of 2)

Agenda: On May 16, 2012, the committee will discuss the evaluation of possible new plasma products frozen following in-process storage at room temperature for up to 24 hours, namely plasma for transfusion prepared from Whole Blood held at room temperature for up to 24 hours prior to separation and freezing, or from apheresis plasma held at room temperature for up to 24 hours before freezing. In the afternoon, the committee will hear update presentations on the following topics: HHS activities related to the evaluation of the donor deferral policy for men who have had sex with other men; a summary of the November 8-9, 2011, public workshop on hemoglobin standards and maintaining an adequate blood supply; and a summary of the November 29, 2011, public workshop on data and data needs to advance risk assessment for emerging infectious diseases for blood and blood products.

Blood Products Advisory Committee

Blood Products Advisory Committee
Committee Meeting May 15 from 8:30 a.m. to approximately 5:00 p.m. (Day 1 of 2)

Agenda : On May 15, 2012, the committee will discuss as a device panel the evaluation of the safety and effectiveness of the OraQuick In-Home HIV Test

Pediatric Advisory Committee Meeting

Pediatric Advisory Committee Meeting
Committee Meeting May 8, 2012 9:00 a.m. - 11:30 p.m. (Day 2 of 2)

Agenda: On Tuesday, May 8, 2012, the Pediatric Advisory Committee will meet regarding the pediatric-focused safety reviews, as mandated by the Pediatric Research Equity Act, for Gardasil Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant, Isopto Carpine (pilocarpine hydrochloride), Menveo Meningococcal (Group A,C,Y, and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine, Zylet (loteprednol etabonate and tobramycin) and Zymaxid (gatifloxacin).

Pediatric Advisory Committee Meeting

Pediatric Advisory Committee Meeting
Committee Meeting May 7, 2012 8:00 a.m. - 5:30 p.m. (Day 1 of 2)

Agenda: On Monday, May 7, 2012, the Pediatric Advisory Committee will meet to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act, for Differin Lotion (adapalene), Dulera Inhalation Aerosol (mometasone furoate and formotorol fumarate), MultiHance Injection (gadobenate dimeglumine), Nasonex (mometasone furoate monohydrate), Natazia (estradiol valerate and estradiol valerate/dienogest), Omnaris Nasal Spray (ciclesonide), Protonix (pantoprazole), Tamiflu (oseltamivir phosphate), Taxotere (docetaxel) and Viread (tenofovir disoproxil fumarate). The committee will also receive an Informational Update on FDA''''s KidNet pilot study.

Circulatory System Devices Panel of the Medical Devices Advisory Committee

Circulatory System Devices Panel of the Medical Devices Advisory Committee
Committee Meeting May 24, 2012 8:00 a.m. - 6:00 p.m

Agenda: On May 24, 2012, the committee will discuss current knowledge about the safety and effectiveness of the AMPLATZER ASO Device & Gore HELEX ASD Occluder as transcatheter Atrial Septal Defect (ASD) occluders used for the closure of secundum atrial septal defects. The AMPLATZER Septal Occluder (ASO) Device was the first device introduced to the US market in 2001 followed by the Gore HELEX device in 2006. With more widespread use of these devices, more information has become available regarding adverse events. These events range from rare life-threatening events to more common events that are perceived to have less severe clinical sequelae. Many of these events were evident in the premarket studies; however, rare events such as erosion were not seen. The purpose of discussion of these events is: (1) to discuss the significance of these events in the overall context of the disease and existing treatment options; (2) to discuss whether additional measures should be taken to improve protection of the public health (e.g., additional study and/or data analyses, labeling changes); and (3) to communicate to patients and physicians what is and is not known about device treatment options.

Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee

Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee
Committee Meeting May 11th, 2012 8:00 a.m. - 6:00 p.m. (Day 2 of 2)

Agenda: On May 10 and 11, 2012, the committee will discuss general issues related to medical devices intended for obese patients. The committee will provide recommendations regarding trial design for clinical studies to evaluate the safety and effectiveness of weight loss devices placed either endoscopically (balloons and suture devices) or laparoscopically (bands, space-occupying devices, etc.) and contrast those to surgery. Additional discussion will include issues pertaining to clinically meaningful weight loss, when the primary endpoint should be measured, length of patient followup, and how much risk is acceptable for a potentially small amount of weight loss.

Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee

Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee
Committee Meeting May 10th, 2012 8:00 a.m. - 6:00 p.m. (Day 1 of 2)

Agenda: On May 10 and 11, 2012, the committee will discuss general issues related to medical devices intended for obese patients. The committee will provide recommendations regarding trial design for clinical studies to evaluate the safety and effectiveness of weight loss devices placed either endoscopically (balloons and suture devices) or laparoscopically (bands, space-occupying devices, etc.) and contrast those to surgery. Additional discussion will include issues pertaining to clinically meaningful weight loss, when the primary endpoint should be measured, length of patient followup, and how much risk is acceptable for a potentially small amount of weight loss.

Antiviral Drugs Advisory Committee

Antiviral Drugs Advisory Committee
Committee Meeting on May 11, 2012, from 8 a.m. to 5 p.m.

Agenda: The committee will discuss new drug application (NDA) 203-100, for a fixed dose combination tablet of elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate, submitted by Gilead Sciences, Inc. The application proposes an indication for the treatment of HIV-1 infection in adults who are antiretroviral naïve or have no known substitutions associated with resistance to the individual components

Gastrointestinal Drugs Advisory Committee

Gastrointestinal Drugs Advisory Committee
Committee Meeting May 31, 2012, from 8 a.m. to 4:30 p.m.

Agenda: The committee will discuss new drug application (NDA) 200–436, synthetic human secretin, sponsored by Repligen Corporation, proposed for use with magnetic resonance imaging (MRI) to improve pancreatic duct visualization for the detection of duct abnormalities to enhance clinical decision making in patients with known or suspected pancreatitis.

Endocrinologic and Metabolic Drugs Advisory Committee

Endocrinologic and Metabolic Drugs Advisory Committee
Committee Meeting on May 10th from 8:00 a.m. to 5:00 p.m.

Agenda: The committee will discuss the safety and efficacy of new drug application (NDA) 22–529 (lorcaserin hydrochloride) tablets, manufactured by Arena Pharmaceuticals, Inc., as an adjunct to diet and exercise for weight management in patients with a body mass index (BMI) equal to or greater than 30 kilograms (kg) per square meter or a BMI equal to or greater than 27 kg per square meter if accompanied by weight-related comorbidities.

Circulatory System Devices Panel of the Medical Devices Advisory Committee

Circulatory System Devices Panel of the Medical Devices Advisory Committee
[Committee Meeting April 26th from 8:00 a.m. to 6:00 p.m. (Day 2 of 2)

Agenda: On April 26, 2012, the committee will discuss, make recommendations and vote on information related to the PMA for the Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System sponsored by Cameron Health, Inc. The S-ICD is the first implantable defibrillator that does not require the implantation of an electrode either on or in the heart. The S-ICD is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias. The device is capable of delivering high energy defibrillation shocks as well as bradycardia demand mode cardiac pacing. The study provides data from the treatment of induced acute and chronic episodes of ventricular tachycardia/ventricular fibrillation and spontaneous episodes. In addition to the investigational device exemption study, clinical data were also obtained from using studies outside the United States and registries.

Circulatory System Devices Panel of the Medical Devices Advisory Committee

Circulatory System Devices Panel of the Medical Devices Advisory Committee
Committee Meeting April 25th from 8:00 a.m. to 6:00 p.m. (Day 1 of 2)

Agenda: On April 25, 2012, the committee will discuss, make recommendations and vote on information related to a supplement to the premarket approval application (PMA) for the HeartWare Ventricular Assist System (HVAS) sponsored by HeartWare, Inc. The HVAS is an implantable electrically powered centrifugal-flow rotary blood pump with external driver and power source(s). It is the first ventricular assist device that does not require the creation of an abdominal pump pocket. The HVAS is indicated for use as a bridge to cardiac transplantation in patients who are at risk of death from refractory, advanced heart failure.

Antiviral Drugs Advisory Committee Meeting

Antiviral Drugs Advisory Committee Meeting
Committee Meeting May 10, 2012 8:00 a.m. to 5:30 p.m.

Agenda: On May 10, 2012, the committee will discuss an efficacy supplement for new drug application (NDA) 21-572, TRUVADA (emtricitabine/tenofovir disoproxil fumarate) Tablet, submitted by Gilead Sciences, Inc. The supplemental application proposes an indication for Pre-Exposure Prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection.

Arthritis Advisory Committee Meeting

Arthritis Advisory Committee Meeting
Committee Meeting May 9, 2012 8:00 a.m. to 5:00 p.m. (Day 2 of 2)

Agenda: On May 9, 2012, the committee will discuss new drug application (NDA) 203214, tofacitinib tablets, Pfizer Inc., for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs).

Assessment of Analgesic Treatment of Chronic Pain--A Public Workshop

Assessment of Analgesic Treatment of Chronic Pain--A Public Workshop
Committee Meeting May 31st, 2012 from 8:00 a.m. to 5:15 p.m. (Day 2 of 2)

Agenda: The purpose of the meeting is to provide a forum to discuss the available data on the use of analgesics in the treatment of CNCP, beginning with a discussion of the underlying mechanisms of chronic pain and the epidemiology of chronic pain in the United States. Next, data on the efficacy of opioids and other analgesics in the treatment of chronic pain from a variety of sources will be reviewed. Those sources will include randomized controlled trials, epidemiological studies, case series and other types of studies. Patient and clinician perspectives on the pharmaceutical treatment of CNCP will be presented by people living with chronic pain and those who treat or care for patients with chronic pain. Finally, a general assessment of the available data and discussion of future research needs and next steps will be used to inform future actions that can help guide appropriate therapy for patients with CNCP.

Assessment of Analgesic Treatment of Chronic Pain--A Public Workshop

Assessment of Analgesic Treatment of Chronic Pain--A Public Workshop
Committee Meeting May 30th, 2012 from 8:00 a.m. to 5:15 p.m. (Day 1 of 2)

Agenda: Agenda: The purpose of the meeting is to provide a forum to discuss the available data on the use of analgesics in the treatment of CNCP, beginning with a discussion of the underlying mechanisms of chronic pain and the epidemiology of chronic pain in the United States. Next, data on the efficacy of opioids and other analgesics in the treatment of chronic pain from a variety of sources will be reviewed. Those sources will include randomized controlled trials, epidemiological studies, case series and other types of studies. Patient and clinician perspectives on the pharmaceutical treatment of CNCP will be presented by people living with chronic pain and those who treat or care for patients with chronic pain. Finally, a general assessment of the available data and discussion of future research needs and next steps will be used to inform future actions that can help guide appropriate therapy for patients with CNCP.

Arthritis Advisory Committee Meeting

Arthritis Advisory Committee Meeting
Committee Meeting May 8th from 8:00 a.m. to 5:00 p.m.

Agenda: On May 8, 2012, the committee will discuss supplemental biologics license application 125249, ARCALYST (rilonacept) injection, Regeneron Pharmaceuticals, Inc., for the following proposed indication: "ARCALYST (rilonacept) is an interleukin-1 blocker indicated for the prevention of gout flares during initiation of uric-acid lowering therapy in adult patients with gout. ARCALYST has not been studied for longer than 16 weeks in this clinical setting.

Radiological Devices Panel of the Medical Devices Advisory Committee

Radiological Devices Panel of the Medical Devices Advisory Committee
Committee Meeting April 12, 2012 from 8:00 a.m. – 6:00 p.m. (Day 2 of 2)

Agenda: On April 12, 2012, during session I, the committee will discuss and make recommendations regarding the 515(i) order issued by FDA on April 9, 2009 (74 FR 16214), for breast transilluminators, one of the remaining preamendments class III devices. On July 18, 1995 (60 FR 36639), FDA published a Final Rule that misbranded breast transilluminators and effectively placed them in class III based on the recommendation of the Obstetrics and Gynecology Devices Panel, which concluded there were no published studies or clinical data demonstrating the safety and effectiveness of this device. The committee discussion will include a review of the present literature to assess the current knowledge of breast transilluminators and determine if sufficient safety and effectiveness data are available to support reclassification of breast transilluminators.

During session II on April 12, 2012, the committee will discuss and make recommendations regarding the classification of blood irradiators. Blood irradiators have been found to be substantially equivalent to predicate devices marketed in interstate commerce prior to May 28, 1976, and are subject to the general controls provisions of the Federal Food, Drug and Cosmetic Act. These devices have never been formally classified. There is an agreement between the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) that outlines which FDA center will regulate these devices. CDRH regulates irradiators intended for use in the immunologically active cells in blood and other tissues and CBER regulates irradiators intended for use in the in-process inactivation of HIV viruses or other pathogens. The committee discussion will focus on whether these devices should be classified in class I, II, or III.

Radiological Devices Panel of the Medical Devices Advisory Committee

Radiological Devices Panel of the Medical Devices Advisory Committee
Committee Meeting April 11, 2012 from 8:00 a.m. – 6:00 p.m. (Day 1 of 2)

Agenda: On April 11, 2012, the committee will discuss, make recommendations, and vote on information related to a premarket approval application for the Automated Breast Ultrasound (ABUS) scanning device, sponsored by U-Systems, Inc. The ABUS scanning device is intended to increase breast cancer detection in asymptomatic dense-breasted women following a negative screening mammogram.

Anti-Infective Drugs Advisory Committee Meeting

Anti-Infective Drugs Advisory Committee Meeting
Committee Meeting April 4th From 8:00 a.m. to 3:30 p.m. (Day 2 of 2)

Agenda: On April 4, 2012, the committee will discuss the data provided to support the safety and efficacy of levofloxacin for the treatment of pneumonic plague in humans. Johnson and Johnson Pharmaceutical Research and Development, LLC (on behalf of Janssen Pharmaceuticals, Inc.) has submitted efficacy supplements for Levaquin (levofloxacin) tablets, injection, and oral solution (NDA 20-634, NDA 20-635, and NDA 21-721, respectively) for treatment of pneumonic plague. Efficacy data for levofloxacin is based on treatment in an animal model of plague. Safety and other supportive information is derived from clinical studies and post-marketing experience in humans.

Anti-Infective Drugs Advisory Committee Meeting

Anti-Infective Drugs Advisory Committee Meeting
Committee Meeting April 3rd From 8:00 a.m. to 5:30 p.m. (Day 1 of 2)

Agenda: On April 3, 2012, during the morning session, the committee will discuss the development of an animal model of pneumonic plague (plague infection with extensive lung involvement) in African Green monkeys and provide advice concerning the relevance of the animal model to pneumonic plague in humans resulting from exposure to Yersinia pestis (the bacteria that causes plague) in a bioterrorism event.

During the afternoon session, the committee will discuss the data provided to support the safety and efficacy of ciprofloxacin for the treatment of pneumonic plague in humans. The National Institute of Allergy and Infectious Diseases (NIAID) has submitted efficacy data for ciprofloxacin, based on treatment in an animal model of plague. Safety and other supportive information is derived from clinical studies and post-marketing experience in humans.

Joint Meeting of the Anti-Infective Drugs Advisory Committee and the Nonprescription Drugs Advisory Committee

Joint Meeting of the Anti-Infective Drugs Advisory Committee and the Nonprescription Drugs Advisory Committee
Committee Meeting April 2, 2012 8:00 a.m. to 5:00 p.m.

Agenda: The committees will provide advice on types of consumer studies needed to assess proper use of a MedKit containing doxycycline to be taken in the event of anthrax exposure. Issues such as the feasibility of an FDA-approved MedKit as a public health strategy, the role of personal MedKits, home stockpiling, and interfaces of home readiness with public health systems, will be raised in the course of the discussions. The Biomedical Advanced Research and Development Authority will propose a possible plan for a step-wise development program for MedKits containing oral doxycycline hyclate.

Endocrinologic and Metabolic Drugs Advisory Committee

Endocrinologic and Metabolic Drugs Advisory Committee
Committee March 29, 2012 from 8:00 to 5:00 (Day 2 of 2)

Agenda: On both days, the committee will discuss the role of cardiovascular assessment in the preapproval and postapproval settings for drugs and biologics developed for the treatment of obesity.

Endocrinologic and Metabolic Drugs Advisory Committee

Endocrinologic and Metabolic Drugs Advisory Committee
Committee March 28, 2012 from 8:00 to 5:00 (Day 1 of 2)

Agenda: On both days, the committee will discuss the role of cardiovascular assessment in the preapproval and postapproval settings for drugs and biologics developed for the treatment of obesity.

Cardiovascular and Renal Drugs Advisory Committee

Cardiovascular and Renal Drugs Advisory Committee
Committee Meeting March 27, 2012 8:00 a.m. to 5:00 p.m.

Agenda: On March 27, 2012, from 11:00 a.m. to 5:00 p.m. the committee will discuss biologics license application (BLA) 125410, proposed tradename REPLAGAL (agalsidase alfa), submitted by Shire Human Genetics Therapies, for an enzyme replacement therapy (ERT) for patients with Fabry disease.

Utilizing Innovative Technologies and Other Conditions of Safe Use To Expand Access to Nonprescription Drugs

Utilizing Innovative Technologies and Other Conditions of Safe Use To Expand Access to Nonprescription Drugs
Committee Meeting March 23rd from 9:00 a.m. to 4:00 p.m. (Day 2 of 2)

Agenda: The U.S. Food and Drug Administration (FDA or the Agency) is announcing a public hearing to obtain input on a new paradigm we are considering. Under this paradigm, the Agency would approve certain drugs that would otherwise require a prescription for nonprescription use (also known as over-the-counter or OTC) under conditions of safe use. These conditions of safe use would be specific to the drug product and might require sale in certain pre-defined healthcare settings, such as a pharmacy. This public hearing is being held to obtain information and comments from the public on the feasibility of this paradigm and its potential benefits and costs.

Utilizing Innovative Technologies and Other Conditions of Safe Use To Expand Access to Nonprescription Drugs

Utilizing Innovative Technologies and Other Conditions of Safe Use To Expand Access to Nonprescription Drugs
Committee Meeting March 22nd from 9:00 a.m. to 4:00 p.m. (Day 1 of 2)

Agenda: The U.S. Food and Drug Administration (FDA or the Agency) is announcing a public hearing to obtain input on a new paradigm we are considering. Under this paradigm, the Agency would approve certain drugs that would otherwise require a prescription for nonprescription use (also known as over-the-counter or OTC) under conditions of safe use. These conditions of safe use would be specific to the drug product and might require sale in certain pre-defined healthcare settings, such as a pharmacy. This public hearing is being held to obtain information and comments from the public on the feasibility of this paradigm and its potential benefits and costs.

Assessment of Analgesic Treatment of Chronic Pain--A Public Workshop

Assessment of Analgesic Treatment of Chronic Pain--A Public Workshop
Committee Meeting May 31st, 2012 from 8:00 a.m. to 5:15 p.m. (Day 2 of 2)

Agenda: The purpose of the meeting is to provide a forum to discuss the available data on the use of analgesics in the treatment of CNCP, beginning with a discussion of the underlying mechanisms of chronic pain and the epidemiology of chronic pain in the United States. Next, data on the efficacy of opioids and other analgesics in the treatment of chronic pain from a variety of sources will be reviewed. Those sources will include randomized controlled trials, epidemiological studies, case series and other types of studies. Patient and clinician perspectives on the pharmaceutical treatment of CNCP will be presented by people living with chronic pain and those who treat or care for patients with chronic pain. Finally, a general assessment of the available data and discussion of future research needs and next steps will be used to inform future actions that can help guide appropriate therapy for patients with CNCP.

Assessment of Analgesic Treatment of Chronic Pain--A Public Workshop

Assessment of Analgesic Treatment of Chronic Pain--A Public Workshop
Committee Meeting May 30th, 2012 from 8:00 a.m. to 5:15 p.m. (Day 1 of 2)

Agenda: Agenda: The purpose of the meeting is to provide a forum to discuss the available data on the use of analgesics in the treatment of CNCP, beginning with a discussion of the underlying mechanisms of chronic pain and the epidemiology of chronic pain in the United States. Next, data on the efficacy of opioids and other analgesics in the treatment of chronic pain from a variety of sources will be reviewed. Those sources will include randomized controlled trials, epidemiological studies, case series and other types of studies. Patient and clinician perspectives on the pharmaceutical treatment of CNCP will be presented by people living with chronic pain and those who treat or care for patients with chronic pain. Finally, a general assessment of the available data and discussion of future research needs and next steps will be used to inform future actions that can help guide appropriate therapy for patients with CNCP.

Neurological Devices Panel of the Medical Devices Advisory Committee

Neurological Devices Panel of the Medical Devices Advisory Committee
Committee meeting on March 23, 2012 from 8:00 a.m. to 7:00 p.m.

Agenda: On March 23, 2012, the committee will discuss current knowledge about the safety and effectiveness of the Wingspan Stent System with Gateway PTA Balloon Catheter for the treatment of intracranial arterial stenosis. FDA is convening this committee to seek expert scientific and clinical opinion on the risks and benefits of this device based on the available premarket and postmarket data. The Wingspan Stent System with Gateway PTA Balloon Catheter is a neurovascular stent, balloon catheter, and delivery system consisting of the following components:

Wingspan Stent--This is a self-expanding, nitinol stent with a tubular mesh design.
Gateway PTA Balloon Catheter--This balloon catheter is used to predilate the lesion prior to introduction of the Wingspan Stent System into the patient.
Wingspan Delivery System--This delivery system is a single lumen, over-the-wire, coaxial microcatheter that is used to deliver the stent to the treatment site within the patient’s artery.

The Wingspan Stent System with Gateway PTA Balloon Catheter has been approved under a humanitarian device exemption (HDE) (H050001) for the following indications: "The Wingspan Stent System with Gateway PTA Balloon Catheter is indicated for use in improving cerebral artery lumen diameter in patients with intracranial atherosclerotic disease, refractory to medical therapy, in intracranial vessels with ≥ 50% stenosis that are accessible to the system.

Gastrointestinal Drugs Advisory Committee Meeting

Gastrointestinal Drugs Advisory Committee Meeting
Committee Meeting March 13th 2012, from 8:00 a.m. to 5:00 p.m.

Agenda: On March 13, 2012 from 8 a.m. to 12:30 p.m., the committee will discuss and provide general advice on the appropriate target populations, objectives and designs of trials intended to evaluate products for the control of hyperbilirubinemia (increased levels of bilirubin in the body) in newborn infants.

Tobacco Products Scientific Advisory Committee

Tobacco Products Scientific Advisory Committee
Committee Meeting March 2, 2012 from 8:00 a.m. to 1:00 p.m. (Day 2 of 2)

Agenda: As part of the TPSAC’s required report to the Secretary of Health and Human Services, the committee will continue discussing issues related to the nature and impact of the use of dissolvable tobacco products on the public health, including such use among children. Discussion will include such topics as the composition and characteristics of dissolvable tobacco products, product use, potential health effects, and marketing.

Tobacco Products Scientific Advisory Committee

Tobacco Products Scientific Advisory Committee
Committee Meeting March 1, 2012 from 1:00 p.m. to 5:00 p.m. (Day 1 of 2)

Agenda: As part of the TPSAC’s required report to the Secretary of Health and Human Services, the committee will continue discussing issues related to the nature and impact of the use of dissolvable tobacco products on the public health, including such use among children. Discussion will include such topics as the composition and characteristics of dissolvable tobacco products, product use, potential health effects, and marketing.

Endocrinologic and Metabolic Drugs Advisory Committee

Endocrinologic and Metabolic Drugs Advisory Committee
Committee March 29, 2012 from 8:00 to 5:00 (Day 2 of 2)

Agenda: On both days, the committee will discuss the role of cardiovascular assessment in the preapproval and postapproval settings for drugs and biologics developed for the treatment of obesity.

Endocrinologic and Metabolic Drugs Advisory Committee

Endocrinologic and Metabolic Drugs Advisory Committee
[Committee March 28, 2012 from 8:00 to 5:00 (Day 1 of 2)]

Agenda: On both days, the committee will discuss the role of cardiovascular assessment in the preapproval and postapproval settings for drugs and biologics developed for the treatment of obesity.

Oncologic Drugs Advisory Committee Meeting

Oncologic Drugs Advisory Committee Meeting
Committee Meeting on March 21, 2012 from 8:00 a.m. to 12:30 p.m. (Day 2 of 2)

The committee will discuss New Drug Application (NDA) 202497, with the proposed trade name Marqibo (vincristine sulfate liposomes injection), application submitted by Talon Therapeutics, Incorporated. The proposed indication (use) for this product is for the treatment of adult patients with Philadelphia Chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL) in second or greater relapse or whose disease has progressed following two or more treatment lines of anti-leukemia therapy.

Oncologic Drugs Advisory Committee Meeting

Oncologic Drugs Advisory Committee Meeting
[Committee Meeting on March 20, 2012 from 8:00 a.m. to 5:00 p.m. (Day 1 of 2)]

During the morning session, the committee will discuss supplemental New Drug Application (sNDA) 022465/S-010, with the trade name Votrient (pazopanib hydrochloride) tablets, application submitted by Glaxo Wellcome Manufacturing Pte Ltd doing business as GlaxoSmithKline. The proposed indication (use) for this product is for the treatment of patients with advanced soft tissue sarcoma (STS) who have received prior chemotherapy. The phase 3 STS trial population excluded patients with adipocytic STS or gastrointestinal stromal tumors (GIST).

During the afternoon session, the committee will discuss New Drug Application (NDA) 022576, with the proposed trade name Taltorvic (ridaforolimus) tablets, application submitted by Merck Sharp & Dohme Corp. The proposed indication (use) for this product is for the treatment of adult and pediatric patients (aged 13 through 17 years with weight over 100 lb or 45.4 kg) with metastatic soft tissue sarcoma or bone sarcoma as a maintenance therapy for patients who have completed at least 4 cycles of chemotherapy without evidence of disease progression.

Pulmonary - Allergy Drugs Advisory Committee

Pulmonary - Allergy Drugs Advisory Committee
Meeting on February 23, 2012, from 8:30 a.m. to 5 p.m.

Agenda: The committee will discuss new drug application 202450, for aclidinium bromide, sponsored by Forest Laboratories, for the proposed indication of long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema.

Blood Products Advisory Committee

Blood Products Advisory Committee
Meeting on February 29, 2012, from 8:30 a.m. to 4 p.m.

Agenda: On February 29, 2012, the committee will discuss the evaluation of possible new plasma products manufactured following storage at room temperature for up to 24 hours, namely, plasma for transfusion prepared from whole blood held at room temperature for up to 24 hours prior to separation and freezing, or from apheresis plasma held at room temperature for up to 24 hours before freezing. In the afternoon, the committee will hear the following updates: Report from the Health and Human Services Advisory Committee on Blood Safety and Availability and summary of the December 5–6, 2011, meeting; update on HHS activities related to the evaluation of the donor deferral policy for men who have had sex with other men; summary of the November 8–9, 2011, public workshop on hemoglobin standard and maintaining an adequate blood supply; summary of the November 29, 2011, public workshop on data and data needs to advance risk assessment for emerging infectious diseases for blood and blood products; and an update on thrombotic adverse events and immune globulin products.

Vaccines and Related Biological Products Advisory Committee

Vaccines and Related Biological Products Advisory Committee
Committee Meeting February 29, 2012 between 8:00 a.m. and 1:00 p.m (Day 2 of 2)

Agenda: On February 29, 2012 the committee will discuss licensure pathways for pandemic influenza vaccines.

Vaccines and Related Biological Products Advisory Committee

Vaccines and Related Biological Products Advisory Committee
Meeting on February 28, 2012 between approximately 8:00 a.m. and 4:00 p.m (Day 1 of 2)

Agenda: On February 28, 2012, the committee will hear an overview of the research program in the Laboratory of Mycobacterial Diseases and Cellular Immunology, Division of Bacterial, Parasitic and Allergenic Products, Office of Vaccines Research and Review, Center of Biologics Evaluation and Research, FDA. The committee will then discuss and make recommendations on the selection of strains to be included in the influenza virus vaccine for the 2012-2013 influenza season. The committee will also hear an update on Pandemic Influenza Surveillance.

Advisory Committee for Pharmaceutical Science and Clinical Pharmacology

Advisory Committee for Pharmaceutical Science and Clinical Pharmacology
Meeting on March 14, 2012, from 7:30 a.m. to 3 p.m.

Agenda: The committee will discuss the clinical pharmacology aspects of pediatric clinical trial design and dosing to optimize pediatric drug development. FDA will seek input on how to strategically inform pediatric clinical trial design and dosing by utilizing existing knowledge, including available adult and nonclinical data. The discussion will include the role of modeling and simulation including physiologically-based pharmacokinetic modeling in pediatric drug development. Modeling and simulation is the application of mathematical approaches to predicting what will happen in a clinical trial with pediatric patients when a particular dose of a drug is used.

Arthritis Advisory Committee

Arthritis Advisory Committee
Meeting on March 12, 2012, from 8 a.m. to 5:30 p.m.

Agenda: The committee will discuss the anti-nerve growth factor (Anti-NGF) drug class that is currently under development and the safety issues possibly related to these drugs. These drugs are being developed for the treatment of a variety of chronic painful conditions including osteoarthritis, chronic lower back pain, diabetic peripheral neuropathy, post-herpetic neuralgia, chronic pancreatitis, endometriosis, interstitial cystitis, vertebral fracture, thermal injury, and cancer pain. The committee will be asked to determine whether reports of joint destruction represent a safety signal related to the Anti-NGF class of drugs, and whether the risk benefit balance for these drugs favors continued development of the drugs as analgesics.

Cardiovascular and Renal Drugs Advisory Committee

Cardiovascular and Renal Drugs Advisory Committee
Committee Meeting on February 23, 2012 from 8:00 a.m. to 5:00 p.m.

Agenda: The committee will discuss new drug application (NDA) 203202, proposed trade name NORTHERA (droxidopa capsules), submitted by Chelsea Therapeutics, Inc., for the treatment of symptomatic neurogenic orthostatic hypotension in patients with primary autonomic failure (Parkinson''''s Disease, Multiple System Atrophy, and Pure Autonomic Failure), Dopamine Beta-Hydroxylase Deficiency, and Non-Diabetic Autonomic Neuropathy.

Endocrinologic and Metabolic Drugs Advisory Committee

Endocrinologic and Metabolic Drugs Advisory Committee
Committee Meeting on February 22, 2012 from 8:00 a.m. to 5:00 p.m.

Agenda: On February 22, 2012, the committee will discuss the safety and efficacy of new drug application (NDA) 22-580, proposed trade name QNEXA (phentermine/topiramate) Controlled-Release Capsules, manufactured by VIVUS, Inc., as an adjunct to diet and exercise for weight management in patients with a body mass index (BMI) equal to or greater than 30 kilograms (kg) per square meter or a BMI equal to or greater than 27 kg per square meter if accompanied by weight-related comorbidities.

Anesthetic and Analgesic Drug Products Advisory Committee

Anesthetic and Analgesic Drug Products Advisory Committee,
Committee Meeting on February 9, 2012, from 8:30 a.m. to 4 p.m.

Agenda: The committee will discuss the available efficacy and safety data for supplemental new drug application (sNDA) 22395/S-013, QUTENZA (capsaicin 8%) Patch, by NeurogesX, Inc., for the proposed indication of management of neuropathic pain (nerve pain) related to HIV-associated peripheral neuropathy (nerve pain in the periphery of the body, such as the feet and legs).

Oncologic Drugs Advisory Committee

Oncologic Drugs Advisory Committee
Committee Meeting on February 9, 2012 from 8:00 a.m. to 5:00 p.m. (Day 2 of 2)]

Agenda: On February 9, 2012, during the morning session, the committee will discuss supplemental new drug application (NDA) 21790/010 for DACOGEN (decitabine) for injection, application submitted by Eisai, Inc. The proposed indication (use) for this product is for the treatment of acute myelogenous leukemia (AML) in adults 65 years of age or older who are not considered candidates for induction chemotherapy, which is the standard first phase of treatment for AML.

During the afternoon session, the committee will discuss NDA 022481, with the proposed trade name PIXUVRI (pixantrone dimaleate) injection, application submitted by Cell Therapeutics, Inc. The proposed indication (use) for this product is as a single agent treatment for patients with relapsed or refractory (difficult to treat), aggressive Non-Hodgkin’s Lymphoma who received two or more prior lines of therapy.

Oncologic Drugs Advisory Committee

Oncologic Drugs Advisory Committee
Committee Meeting on February 8, 2012 from 8:00 a.m. to 12:30 p.m. (Day 1 of 2)]

Agenda: The committee will discuss supplemental biologics license application 125320/28 for XGEVA (denosumab) injection, application submitted by Amgen Inc. The proposed indication (use) for this product is for the treatment of men with castrate-resistant prostate cancer at high risk of developing bone metastases, or spread of cancer to the bones.

Pediatric Advisory Committee

Pediatric Advisory Committee
Committee Meeting on January 30, 2012 from 9 a.m. to 12 p.m. (Day 2 of 2)]

Agenda: The Pediatric Advisory Committee will meet to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act for Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein), Cervarix (Human Papillomavirus Bivalent (Types 16 and 18) vaccine, recombinant, Focalin XR (dexmethylphenidate), Daytrana (methylphenidate), Seroquel (quetiapine), Pancreaze (pancrelipase), Zenpep (pancrelipase), Creon (pancrelipase), Xerese cream 5%/1% (acyclovir and hydrocortisone), Xolair (omalizumab), Benicar (olmesartan medoxomil), Atacand (candesartan cilexetil), Mirena (levonorgestrel— releasing intrauterine system), Plan B One Step (levonorgestrel), and Flomax (tamsulosin).

Pediatric Advisory Committee

Pediatric Advisory Committee
Committee Meeting on January 30, 2012 from 8 a.m. to 4 p.m. (Day 1 of 2)]

Agenda: The Pediatric Advisory Committee will meet to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act for Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein), Cervarix (Human Papillomavirus Bivalent (Types 16 and 18) vaccine, recombinant, Focalin XR (dexmethylphenidate), Daytrana (methylphenidate), Seroquel (quetiapine), Pancreaze (pancrelipase), Zenpep (pancrelipase), Creon (pancrelipase), Xerese cream 5%/1% (acyclovir and hydrocortisone), Xolair (omalizumab), Benicar (olmesartan medoxomil), Atacand (candesartan cilexetil), Mirena (levonorgestrel— releasing intrauterine system), Plan B One Step (levonorgestrel), and Flomax (tamsulosin).

Pediatric Advisory Committee

Pediatric Advisory Committee
Committee Meeting on January 30, 2012 from 8 a.m. to 4 p.m. (Day 1 of 2)]

Agenda: The Pediatric Advisory Committee will meet to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act for Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein), Cervarix (Human Papillomavirus Bivalent (Types 16 and 18) vaccine, recombinant, Focalin XR (dexmethylphenidate), Daytrana (methylphenidate), Seroquel (quetiapine), Pancreaze (pancrelipase), Zenpep (pancrelipase), Creon (pancrelipase), Xerese cream 5%/1% (acyclovir and hydrocortisone), Xolair (omalizumab), Benicar (olmesartan medoxomil), Atacand (candesartan cilexetil), Mirena (levonorgestrel— releasing intrauterine system), Plan B One Step (levonorgestrel), and Flomax (tamsulosin).