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).