AstraZeneca (NYSE: AZN) submitted a NDA seeking FDA approval for a combination of low-dose aspirin and esomeprazole (the generic name for the stomach medicine better known as Nexium or the purple pill). AZN is filing for approval of the combination product to reduce the risk of gastric (stomach) and/or duodenal (small intestinal) ulcers in patients at risk for this side effect of aspirin therapy.
AZN also submitted a sNDA for Nexium to expand its label to include the risk reduction of low-dose aspirin gastric and/or duodenal ulcers. Nexium is already approved for reducing the risk of stomach ulcers associated with regular use of non-steroidal anti-inflammatory drugs (NSAIDs - e.g. ibuprofen and naproxen) in patients at risk for developing gastric ulcers.
GlaxoSmithKline (NYSE: GSK) and Genmab (CPH: GEN) (PINK: GNMSF) announced today that a FDA Advisory panel will review the Company's pending BLA for cancer drug Arzerra (ofatumumab) on 5/29/09. The BLA was filed in January and the FDA accepted the filing in April with priority review (six-month) status.
Sanofi-Aventis (NYSE:SNY) has not yet received a final decision from the FDA on its pending NDA for heart drug Multaq (dronedarone) in the treatment of atrial fibrillation (a type of irregular heartbeat). In March, a FDA panel of cardiology experts recommended that Multaq should be approved with a 10-3 vote. The original PDUFA decision date was 4/30/09, but a decision is now expected to occur some time during 2Q09 based on a company update on 5/4/09.
A full report on the developments is available on the BiomedReport's FDA Calendar, which includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), and pending re-submissions to the FDA for complete response rulings by the agency which require more information before an approval can be granted.
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