Court enjoins FDA on blood pressure drug |
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Tue, 27 Mar 2007 13:53
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PITTSBURGH (AP) - Generic drug maker Mylan Laboratories Inc. said Tuesday a U.S. court ordered the Food and Drug Administration not to approve any more abbreviated new drug applications for generic forms of Pfizer's blood pressure drug, Norvasc, until at least April 13.Mylan's amlodipine besylate tablets are the generic version of Norvasc tablets. The enjoinment covers 2.5 mg, 5mg and 10mg tablets.The FDA said it will solicit views of interested parties by April 4 and will have an agency decision on April 11.Mylan triggered a 180-day exclusivity period for all strengths of amlodipine besylate when it launched the generic Norvasc on March 23.Copyright 2007 Associated Press. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
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