FDA Tracker » Podcast
Summary: Audio recordings of FDA advisory committee webcasts. Provided by www.fdatracker.com, scientific and behavioral analysis of FDA advisory committee and PDUFA date decisions
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- Artist: Joseph Lee
Podcasts:
On March 4, 2013, during the afternoon session, the committee will discuss NDA 204516, paroxetine mesylate 7.5 mg capsules, submitted by Noven Therapeutics, LLC, for the proposed indication of treatment of moderate to severe vasomotor symptoms associated with menopause. Download | iTunes | RSS
On March 4, 2013, during the morning session, the committee will discuss new drug application (NDA) 022506, gabapentin 600 milligram (mg) tablets, submitted by Depomed, Inc., for the proposed indication of treatment of moderate to severe vasomotor symptoms due to menopause. Download | iTunes | RSS
On December 20, 2012, 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. Download | iTunes | RSS
On December 7, 2012, 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 [...]
On October 17, 2012, 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 [...]
On October 16, 2012, 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). Download | iTunes | RSS
On September 5, 2012, 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. Download | iTunes | RSS
On June 20, 2012, 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 [...]
On June 20, 2012, 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 [...]
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 [...]
On May 10, 2012, the committee will discuss an efficacy supplement for new drug application (NDA) 21-752, 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. Download | iTunes | RSS
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). Download | iTunes | RSS
