FDA Blocks New Generic Versions Of Pfizer's Norvasc

Law360, New York (April 20, 2007, 12:00 AM EDT) -- The U.S. Food and Drug Administration has notified Mylan Laboratories that it is the only generic drug maker allowed to sell cheap copies of Pfizer’s blockbuster blood pressure medication, Norvasc, after it blocked approval of all other applicants.

In a letter sent out Wednesday, the FDA said all unapproved applications to make and market amlodipine besylate tablets were blocked by Pfizer’s pediatric exclusivity, which expires Sept. 25.

But the FDA left a window open for drug company Apotex to start selling its version if a court...
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