Food Advisory Committee

Food Advisory Committee

Committee Meeting on March 30 and 31, 2011 from 8:00 a.m. to 4:30 p.m.

Agenda: The Food Advisory Committee will meet to discuss whether available relevant data demonstrate a link between children''''s consumption of synthetic color additives in food and adverse effects on behavior.

Oncologic Drugs Advisory Committee

Oncologic Drugs Advisory Committee

Committee Meeting on February 9, 2011, from 8 a.m. to 12:30 p.m.

Agenda: On February 9, 2011, the committee will discuss biologics license application (BLA) 125377, with the proposed trade name YERVOY(ipilimumab), submitted by Bristol-Myers Squibb Co. The proposed indication (use) for this product is for the treatment of advanced melanoma in patients who have received prior therapy.

Neurological Devices Panel of the Medical Devices Advisory Committee

Neurological Devices Panel of the Medical Devices Advisory Committee

Committee Meeting on January 27 and 28, 2011 from 8:00 a.m. to 6:00 p.m.

Agenda: On January 27 and 28, 2011, the committee will discuss and make recommendations regarding the possible reclassification of devices indicated for use in electroconvulsive therapy.

Peripheral and Central Nervous System Drugs Advisory Committee

Peripheral and Central Nervous System Drugs Advisory Committee

Committee Meeting on January 21, 2011, from 8 a.m. to 12 p.m.

On January 21, 2011, the committee will discuss NDA 201-277, gadobutrol injection, sponsored by Bayer HealthCare Pharmaceuticals, proposed for use in diagnostic magnetic resonance imaging (MRI) in adults and children (2 years of age and older) to detect and visualize areas with disrupted blood brain barrier (BBB) and/or abnormal vascularity (abnormal blood supply and circulation) of the central nervous system. The BBB is an area consisting of specialized cells that restrict passage of certain molecules from the bloodstream into the brain.

Peripheral and Central Nervous System Drugs Advisory Committee

Peripheral and Central Nervous System Drugs Advisory Committee
Committee Meeting on January 20, 2011, from 8 a.m. to 5 p.m.

Agenda: On January 20, 2011, the committee will discuss new drug application (NDA) 202-008,florbetapir F 18 injection, sponsored by Avid Radiopharmaceuticals, Inc., proposed for use in positron emission tomography (PET) imaging of [beta]-amyloid (beta-amyloid) aggregates in the brain to help rule out Alzheimer''s disease.

Medicare Program; Meeting of the Medicare Evidence Development and Coverage Advisory Committee

Medicare Program; Meeting of the Medicare Evidence Development and Coverage Advisory Committee

Committee Meeting on Wednesday, January 19, 2011, from 7:30 a.m. to 4:30 p.m.

SUMMARY: This notice requests nominations for consideration for membership on the Medicare Coverage Advisory Committee (MCAC). The Committee provides advice and recommendations about whether scientific evidence is adequate to determine whether certain medical items and services are reasonable and necessary under the Medicare statute.

Gastrointestinal Drugs Advisory Committee

Gastrointestinal Drugs Advisory Committee

Committee Meeting on January 12, 2011, from 8 a.m. to 5:00 p.m.

Agenda: On January 12, 2011, the committee will discuss the safety and efficacy of new drug application (NDA)022–486, for Solpura (liprotamase) Capsules, by Alnara Pharmaceuticals, for the proposed indication (use) in the treatment of exocrine pancreatic insufficiency due to cystic fibrosis, chronic pancreatitis, pancreatectomy (surgical removal of all or part of the pancreas), or other conditions that may impair or limit function of the pancreas. The pancreas is an organ involved, in part, in the digestion of food through the use of specialized proteins called enzymes. Exocrine pancreatic insufficiency is a decreased ability to digest food due to deficient enzyme production by the pancreas.

Tobacco Products Scientific Advisory Committee

Tobacco Products Scientific Advisory Committee

Committee Meeting on January 10th and 11th 2011, from 8 a.m. to 5:00 p.m.

Agenda: On January 10 and 11, 2011, the Committee will continue to (1) receive updates from the Menthol Report Subcommittee and (2) receive and discuss presentations regarding the data requested by the Committee at the March 30 and 31, 2010, meeting of the Tobacco Products Scientific Advisory Committee.

Pediatric Advisory Committee

Pediatric Advisory Committee

December 7, 2010, from 8 a.m. to 6 p.m.

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 Prevista (darunavir ethanolate), PegIntron (peginterferon alfa-2b), Xyzal(levocetirizine dihydrochloride) tablet and solution, Flovent HFA (fluticasone propionate), Acanya Gel (clindamycin/benzoyl peroxide combination), Epiduo Gel (adapalene and benzoyl peroxide), Ulesfia Lotion 5% (benzyl alcohol), Axert (almotriptan), Gardasil (human papillomavirus quadrivalent types 6, 11, 16, 18, vaccine recombinant), Lamictal and Lamictal XR (lamotrigine), and Neulasta (pegfilgrastim). The committee will also receive a followup on Depakote ER (divalproex sodium). Committee members who participated in the Cardiovascular and Renal Drugs Advisory Committee and the Gastrointestinal Drugs Advisory Committee meetings held on July 29, 2010, and November 5, 2010, respectively, will provide a brief summary of the meetings.

Endocrinologic and Metabolic Drugs Advisory Committee

Endocrinologic and Metabolic Drugs Advisory Committee

December 7, 2010, from 8 a.m. to 5 p.m.

Agenda: On December 7, 2010, the committee will discuss the safety and efficacy of new drug application (NDA) 20-0063, proposed tradename CONTRAVE (naltrexone HCl/bupropion HCl)extended release tablets, manufactured by Orexigen Therapeutics, Inc., for the treatment of obesity and weight management, including weight loss and maintenance of weight loss in patients with an initial body mass index (BMI) of equal to or greater than 30 kilograms (kg) per square meter, or a BMI equal to or greater than 27 kg per square meter with one or more risk factors (e.g. diabetes, dyslipidemia, or hypertension). The BMI is a measure of body weight (mass) based on a person''s weight and height, and is a widely-used tool for doctors in assessing optimum weights for a patient.

Pediatric Advisory Committee

Pediatric Advisory Committee

December 6, 2010, from 8 a.m. to 6 p.m.

Agenda: The Pediatric Advisory Committee (PAC) will meet to discuss donor and banked human milk. FDA is convening the meeting to obtain and discuss information and data that will provide the Agency with a better understanding of current practices, and potential benefits and risks associated with the donation and banking of human milk.

Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee

Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee

December 3 from 8 a.m. to 6 p.m. (Day 2 of 2)

Agenda: On December 3, 2010, the committee will discuss, make recommendations, and vote on information related to the PMA for the LAP-BAND Adjustable Gastric Banding System, sponsored by Allergan. The sponsor is requesting an expanded Indication for Use for their LAP-BAND Adjustable Gastric Banding System to include weight reduction in patients with a Body Mass Index (BMI) of at least 35 kg/m2 or a BMI of at least 30 kg/m2 with one or more comorbid conditions.

Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee

Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee

Meeting on December 2 from 8 a.m. to 6 p.m. (Day 1 of 2)

Agenda: On December 2, 2010, the committee will discuss, make recommendations, and vote on information related to the premarket approval application (PMA) for SOLESTA, sponsored by Oceana Therapeutics, Inc. SOLESTA is indicated for the treatment of fecal incontinence in patients who have failed conservative therapy.

Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee

Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee

December 2, 2010, from 8 a.m. to 4:30 p.m.

Agenda: On December 2, 2010, the committees will begin with a closed session from 8 a.m. to 9:15 a.m. Following the closed session, from 9:15 a.m. to 4:30 p.m., the meeting will be open to the public. The committees will discuss new drug application (NDA) 201655, Oxymorphone HCl Extended-Release Tablets, Endo Pharmaceuticals, Inc., and its safety for the proposed indication of relief of moderate to severe pain in patients requiring continuous, around-the clock opioid treatment for an extended period of time. The extended-release characteristics of this formulation are purportedly less easily defeated than other formulations of controlled-release oxymorphone.

Oncologic Drugs Advisory Committee

Oncologic Drugs Advisory Committee

December 2, 2010, from 8 a.m. to 5 p.m.

Agenda: On December 2, 2010, during the morning session, the committee will discuss biologics license application (BLA) 125377, with the proposed trade name Yervoy (ipilimumab), manufactured by Bristol-Myers Squibb Company. The proposed indication (use) for this product is for the treatment of advanced melanoma in patients who have received prior therapy. During the afternoon session, the committee will discuss new drug application (NDA) 022-405, with the proposed trade name Zictifa (vandetanib) Tablets, manufactured by iPR Pharmaceuticals, Inc., represented by AstraZeneca Pharmaceuticals LP (authorized U.S. agent). The proposed indication (use) for this product is for the treatment of patients with unresectable (non-operable) locally advanced or metastatic medullary thyroid cancer.

Oncologic Drugs Advisory Committee

Oncologic Drugs Advisory Committee

December 1, 2010, from 8 a.m. to 5 p.m.

Agenda: On December 1, 2010, the committee will discuss supplemental new drug applications (sNDAs) 021-319/S-024, trade name AVODART (dutasteride) Soft Gelatin Capsules,manufactured by SmithKline Beecham Corp. d/b/a (doing business as) GlaxoSmithKline and 020-180/S-034, trade name PROSCAR (finasteride)Tablets, manufactured by Merck & Co., Inc. The proposed indication (use) for AVODART (dutasteride) is for reduction in the risk of prostate cancer in men at increased risk of developing the disease. The population at increased risk of prostate cancer includes men with an elevated serum prostate-specific antigen (PSA) or men otherwise determined to be at increased risk based on other associated risk factors such as age, race, and family history. There is no proposedexpansion of the indication for PROSCAR (finasteride); however, in light of the Prostate Cancer Prevention Trial (PCPT) which demonstrated a statistically significant reduction in the 7-year period prevalence of prostate cancer with finasteride (PROSCAR) treatment, and which reported an imbalance in high Gleason grade prostate cancers (indicating more aggressive cancers) in the finasteride treatment arm vs. placebo, the efficacy and safety of both products for use in prostate cancer risk reduction will be examined.

Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee

Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee

November 30, 2010, from 8 a.m. to 5:30 p.m.

Agenda: On November 30, 2010, information will be presented regarding pediatric development plans for four products that were either recently approved by FDA or, are in late stage 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) Crizotinib, manufactured by Pfizer, Inc.; (2) pralatrexate, manufactured by Allos Therapeutics, Inc.; (3) denosumab, manufactured by Amgen, Inc.; and (4) eribulin, manufactured by Eisai Inc.

Cellular, Tissue and Gene Therapies Advisory Committee

Cellular, Tissue and Gene Therapies Advisory Committee

November 19, 2010, from 8:30 a.m. to 5 p.m.

Agenda: On November 19, 2010, the Committee will discuss current FDA recommendations for Testing of Replication Competent Retrovirus (RCR)/Lentivirus (RCL) in Retroviral and Lentiviral Vector Based Gene Therapy Products.

Tobacco Products Scientific Advisory Committee

Tobacco Products Scientific Advisory Committee

November 18, 2010, from 1 p.m. until 5 p.m.

Agenda: On November 18, 2010, the committee will (1) Receive an update on the Menthol Report Subcommittee and (2) receive and discuss presentations regarding the data requested by the committee at the March 30 and 31, 2010, meeting of the Tobacco Products Scientific Advisory Committee.

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

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

November 18, 2010, from 8:00 a.m. to 6:00 p.m

MelaFind -sponsored by MELA Sciences, Inc.

Agenda: On November 18, 2010, the committee will discuss, make recommendations, and vote on premarket approval application for MelaFind, sponsored by MELA Sciences, Inc. MelaFind is a non-invasive computer vision system intended to assist in the evaluation of pigmented skin lesions, including atypical moles, which have one or more clinical or historical characteristics of melanoma, before a final decision to biopsy has been rendered. MelaFind acquires and displays multi-spectral (from blue to near infrared) digital images of pigmented skin lesions and uses automatic image analysis and statistical pattern recognition to help identify lesions to be considered for biopsy to rule out melanoma.

On Label and Off-Label Use of Autologous Cellular Immunotherapy Treatment of Metastatic Prostate Cancer,

On Label and Off-Label Use of Autologous Cellular Immunotherapy Treatment of Metastatic Prostate Cancer

Committee Meeting on November 17, 2010 8:00 a.m. TO 5:00 p.m

Provenge - Sponsored by Denedron

Agenda: The Centers for Medicare and Medicaid Services (CMS) has called this meeting to consider the currently available evidence regarding the impact of labeled and unlabeled use of autologous cellular immunotherapy treatment on health outcomes of patients with metastatic prostate cancer. As described on the FDA website at http://www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/ucm213559.htm, PROVENGE (Sipuleucel T, APC8015) is an autologous cellular immunotherapy product consisting of peripheral blood mononuclear cells (PBMCs) obtained from patients by leukapheresis and activated in vitro with a recombinant fusion protein (prostatic acid phosphatase fused with GM-CSF). FDA will require the sponsor to complete a post marketing study to evaluate the risk of stroke in patients who receive sipuleucel-T. Provenge has FDA approved labeling for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.

Vaccines and Related Biological Products Advisory Committee,

Vaccines and Related Biological Products Advisory Committee

November 17, 2010, from 8:30 a.m. to 1:15 p.m. (Day 2 of 2)

Gardasil manufactured by Merck & Co.


Agenda: On November 17, 2010, the committee will meet in open session to review and discuss the effectiveness of vaccinating males and females with Gardasil manufactured by Merck & Co. for the prevention of anal dysplasia and anal cancer.

Vaccines and Related Biological Products Advisory Committee,

Vaccines and Related Biological Products Advisory Committee,

November 16, 2010, from 9 a.m. to 4 p.m. (Day 1 of 2)

Agenda: On November 16, 2010, the committee will meet in open session to review and discuss the pathway to licensure for protective antigen-based anthrax vaccines for a post-exposure prophylaxis indication using the animal rule.

Arthritis Advisory Committee

Arthritis Advisory Committee

November 16th 2010, , from 8:00 a.m. to 5:00 p.m

belimumab, proposed trade name BENLYSTA - Sponsored by Human Genome Sciences

Agenda: On November 16, 2010, the committee will discuss biologic license application 125370, belimumab, proposed trade name BENLYSTA, sponsored by Human Genome Sciences, for the proposed indication of reducing disease activity in adult patients with active, autoantibody-positive systemic lupus erythematosus

June 2nd Antiviral Drugs AdComm - motavizumab (MedImmune) - FDAAC.com

June 2, 2010 – Antiviral Drugs Advisory Committee

BLA – motavizumab (MedImmune)

Agenda: On June 2, 2010, the committee will discuss biologics license application (BLA) 125283, motavizumab, MedImmune, LLC, proposing an indication for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in children at high risk of RSV disease.

May 12th Arthritis Drugs and DSRM AdComm - NAPROXCINOD (NicOx) - FDAAC.com

May 12, 2010 – Arthritis Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee

NDA – naproxcinod (NicOx)

Agenda: On May 12, 2010, the committees will discuss new drug application (NDA) 22-478, naproxcinod 375 milligram capsule, sponsored by NicOx S.A., a non-steroidal anti-inflammatory drug (NSAID) product indicated for the treatment of the signs and symptoms of osteoarthritis.

May 27th EndoMet Drugs AdComm - EGRIFTA (Theratechnologies) - FDAAC.com

May 27, 2010 – Endocrinologic and Metabolic Drugs Advisory Committee

NDA – EGRIFTA (Theratechnologies)

Agenda: On May 27, 2010, the committee will discuss the safety and efficacy of new drug application (NDA) 22-505, EGRIFTA (tesamorelin acetate), sterile lyophilized powder for injection, by Theratechnologies, Inc. EGRIFTA is an analogue (a chemical compound that resembles another compound in structure) of growth hormone releasing hormone (GHRH). The proposed indication (use) for EGRIFTA in this application is to induce and maintain a reduction of excess visceral abdominal fat in human immunodeficiency virus (HIV)-infected patients with lipodystrophy (a condition in which abnormal deposits of fat are seen partly as a result of using certain drugs to treat HIV disease).

April 29th Anti-Infective Drugs AdComm - artesunate (WHO) - Live Webcast at FDAAC.com

April 29, 2010 – Anti-Infective Drugs Advisory Committee

NDA – artesunate rectal suppositories (WHO)

Agenda: On April 29, 2010, the committee will discuss the efficacy and safety of new drug application (NDA) 21-242, artesunate rectal suppositories, submitted by the World Health Organization, for the proposed use as a single dose for the initial treatment of patients with acute malaria who cannot take medication by mouth and for whom injectable treatment is not available.

May 6th PCNS Drugs AdComm - ACTHAR Gel (Questcor) - Live Webcast at FDAAC.com

May 6, 2010 – Peripheral and Central Nervous System Drugs Advisory Committee

sNDA – ACTHAR Gel (Questcor)

Agenda: On May 6, 2010, the committee will discuss supplemental new drug application (sNDA) 22-432, H.P. ACTHAR Gel (repository corticotropin injection), 80 USP units per milliliter, Questcor Pharmaceuticals, proposed for the treatment of infantile spasms.

April 22nd Anesthetic and Life Support Drugs & DSRM AdComm - ACUROX (Acura) - Webcast at FDAAC.com

April 22, 2010 –Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee

NDA – ACUROX (Acura)

Agenda: On April 22, 2010, the committees will discuss new drug application (NDA) 22-451 ACUROX (oxycodone HCl and niacin) Tablets, Acura Pharmaceuticals, Inc., for the proposed indication of relief of moderate to severe pain where the use of an immediate-release, orally administered, opioid analgesic tablet is appropriate, and the results of studies evaluating the addition of niacin, added for the purpose of reducing the misuse of oxycodone.

April 13th & 14th Pharmaceutical Science and Clinical Pharmacology AdComm - FDAAC.com

April 13 &14, 2010 – Advisory Committee for Pharmaceutical Science and Clinical Pharmacology

Agenda: On April 13, 2010, the committee will receive presentations from the Office of Generic Drugs and discuss two bioequivalence topics relevant to generic drug approval: (1) Revising the BE approaches for critical dose drugs and (2) the use of partial area under the curve (AUC) for the evaluation of abbreviated new drug applications for products with complex pharmacokinetic profiles. Bioequivalence refers to the evaluation of equivalence in the rate and extent of drug absorption between two preparations of the same drug. Critical dose drugs are medicines that require a narrow (or ``critical'') dose range to achieve and maintain their intended effects and to reduce serious adverse drug reactions. The ``area under the curve'' is the area under a plot of drug concentration in the bloodstream versus time; it is a measure of the extent of exposure to a drug after a dose is administered.

Agenda: On April 14, 2010, the committee will: (1) Receive presentations from the Office of Generic Drugs (OGD) on a proposal for revision of the bioequivalence (BE) approaches, specifically to discuss the addition of a limitation on point estimates; (2) receive presentations on an awareness topic to highlight some issues associated with product instability (failure of a marketed product to meet stability specifications through the expiration date), and the potential research needs to address those issues; and (3) receive and discuss presentations from Office of Pharmaceutical Science (OPS) on the regulatory challenges of drug-induced phospholipidosis (excessive intracellular accumulation of phospholipids, a kind of fatty molecule, due to the use of certain drugs).

April 7th Pulmonary-Allergy Drugs AdComm - roflumilast/DAXAS (Forest Research) - Webcast at FDAAC.com

April 7, 2010 – Pulmonary-Allergy Drugs Advisory Committee

NDA – roflumilast/DAXAS (Forest Research)

Agenda: On April 7, 2010, the committee will discuss new drug application (NDA) 22-522, roflumilast (DAXAS), Forest Research Institute, for the maintenance treatment of chronic obstructive pulmonary disease associated with chronic bronchitis in patients at risk of exacerbations (worsening symptoms).

March 22nd Oncologic Drugs AdComm - PIXUVRI (Cell Ther) & OMAPRO (ChemGenex) - FDAAC.com

FDAAdvisoryCommittee.com March 22, 2009 – Oncologic Drugs Advisory Committee Agenda: On March 22, 2010, during the morning session, the committee will discuss new drug application (NDA) 022-481, proposed trade name PIXUVRI (pixantrone dimaleate) injection, manufactured by Cell Therapeutics, Inc. The proposed indication (use) for this product is as a single agent treatment for patients with recurring or refractory (difficult to treat), aggressive non-Hodgkin’s lymphoma (NHL) who have received two or more prior lines of therapy.

During the afternoon session, the committee will discuss NDA 022-374, proposed trade name OMAPRO (omacetaxine mepesuccinate) for injection, manufactured by ChemGenex Pharmaceuticals. The proposed indication (use) for this product is for the treatment of adults with chronic myeloid leukemia (CML) bearing a genetic alteration known as the Bcr-Abl T315I mutation, and who have failed prior therapy with the drug imatinib

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March 17th Pharmaceutical Science and Clinical Pharmacology AdComm - FDAAC.com

FDAAdvisoryCommittee.com March 17, 2010 – Advisory Committee for Pharmaceutical Science and Clinical Pharmacology Agenda: On March 17, 2010, the committee will discuss and provide comments on the following topics: (1) General scientific issues related to the application of pharmacogenomics in the early stages of drug development. Pharmacogenomics examines the genetic differences that influence a person's responses, both beneficial and harmful, to certain drugs; (2) a new patient-centric clinical pharmacology approach to drug safety; (3) the design and analysis of clinical pharmacology studies focusing on how the renal function changes in the way the body absorbs, distributes, metabolizes, and excretes a drug in patients with kidney impairment; and (4) scientific considerations and recent developments in transporter-mediated drug interactions. These interactions are between two or more drugs that either inhibit or enhance the roles of specialized proteins known as ``transporters'' and, in turn, the interactions can affect a drug's safety and/or efficacy.

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March 18th & 19th Circulatory System Devices AdComm - CRT-Ds (Boston Scientific) & REVO (Medtronic) - FDAAC.com

FDAAdvisoryCommittee.com

March 18 & 19, 2010 - Circulatory System Devices Panel of the Medical Devices Advisory Committee Committee
PMA - CRT-Ds (Boston Scientific)
PMA - REVO MRI Pacemaker System (Medtronic)
Agenda: On March 18, 2010, the committee will discuss, make recommendations, and vote on the premarket approval application (PMA) for the Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) sponsored by Boston Scientific. The sponsor is seeking expanded indications for the their CRT-Ds to include patients with low left ventricular ejection fraction (<=30%) and wide QRS (>=130 ms) who are NYHA Class II (ischemic or non-ischemic etiology) or NYHA Class I (ischemic etiology).

Agenda: On March 19, 2010, the committee will discuss, make recommendations and vote on a PMA for the REVO MRI Pacemaker System sponsored by Medtronic. The REVO MRI Pacing System is a pacemaker (with a standard pacing indication) that has been specifically designed to be safe for the MRI environment under certain MR scanning conditions.

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March 1, 2010 CardioRenal Drugs Advisory Committee - belatacept injectable (Bristol Myers Squibb) - http://fdaac.com

FDAAdvisoryCommittee.com

March 1, 2010 - Cardiovascular and Renal Drugs Advisory Committee
BLA - belatacept injectable (Bristol Myers Squibb)
Agenda: On March 1, 2010, the committee will discuss biologics license application (BLA) 125288, for belatacept injectable, by Bristol Myers Squibb, to be used in patients with kidney transplants to prevent rejection of the transplanted kidney.

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March 10 & 11, 2010 Pulmonary-Allergy Drugs Advisory Committee - beta-2 adrenergic agonists - http://fdaac.com

FDAAdvisoryCommittee.com

March 10 & 11, 2010 - Pulmonary-Allergy Drugs Advisory Committee
long acting beta-2 adrenergic agonists review
Agenda: On March 10 and 11, 2010, the committee will discuss the design of medical research studies (known as ``clinical trial design'') to evaluate serious asthma outcomes (such as hospitalizations, a procedure using a breathing tube known as intubation, or death) with the use of the class of asthma medications known as long acting beta-2 adrenergic agonists in the treatment of asthma in adults, adolescents, and children.

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March 9, 2010 Pulmonary-Allergy Drugs Advisory Committee - prifenidone (InterMune) - http://fdaac.com

FDAAdvisoryCommittee.com

March 9, 2010 - Pulmonary-Allergy Drugs Advisory Committee
NDA - prifenidone (InterMune)
Agenda: On March 9, 2010, the committee will discuss new drug application (NDA) 22-535, pirfenidone, by InterMune. The proposed indication (purpose) of this drug is the treatment of patients with idiopathic pulmonary fibrosis (scarring of the lungs without a known cause to decrease the decline in lung function associated with this condition.

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February 10, 2010 - Oncologic Drugs Advisory Committee - http://FDAAC.com

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February 10, 2010 - Oncologic Drugs Advisory Committee

NDA - PIXUVRI (Cell Therapeutics)

NDA - OMAPRO (ChemGenex Pharm)

Agenda: On February 10, 2010, during the morning session, the committee will discuss new drug application (NDA) 022-481, proposed trade name PIXUVRI (pixantrone dimaleate) injection, manufactured by Cell Therapeutics, Inc. The proposed indication (use) for this product is as a single agent treatment for patients with recurring or refractory (difficult to treat), aggressive non-Hodgkin’s lymphoma (NHL) who have received two or more prior lines of therapy.

During the afternoon session, the committee will discuss NDA 022-374, proposed trade name OMAPRO (omacetaxine mepesuccinate) for injection, manufactured by ChemGenex Pharmaceuticals. The proposed indication (use) for this product is for the treatment of adults with chronic myeloid leukemia (CML) bearing a genetic alteration known as the Bcr-Abl T315I mutation, and who have failed prior therapy with the drug imatinib.

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