FDA, Clinical Trial Updates: NYSE:WPI, NYSE:NVS

The FDA Calendar 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.

Watson Pharma (NYSE:WPI) confirmed the filing of an Abbreviated New Drug Application (ANDA), with Paragraph IV litigation underway, which is seeking marketing approval of a generic version of an overactive bladder drug called Enablex (darifenacin). Novartis (NYSE:NVS) has filed a lawsuit to prevent generic competition before the patent expires, causing a stay of final FDA approval for the ANDA for a period of 30 months or court resolution (whichever occurs first). According to IMS Health data, Enablex posted U.S. sales of $220M in 2008.

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