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Drug Development
U.S. District Court Enjoins the FDA from Approving Additional Amlodipine Besylate ANDAs
April 10th, 2007
Mylan Laboratories Inc. (NYSE:MYL) was notified yesterday that the U.S. District Court for the District of Columbia has enjoined the U.S. Food and Drug Administration (FDA) from approving any additional Abbreviated New Drug Applications (ANDAs) for Amlodipine Besylate Tablets, 2.5 mg (base), 5 mg (base) and 10 mg (base) from April 11, 2007 until at least April 13, 2007. The FDA has represented to the court that it will be soliciting views of interested parties on this matter by April 4, 2007 and will render an agency decision on April 11, 2007. Mylan triggered its 180 day exclusivity period for all strengths of Amlodipine Besylate when it commercially launched the product on March 23,...
Source: Drug Law Weekly (2007-04-10)
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