FDA Banned From Approving More Generic Norvasc

Law360, New York (March 27, 2007, 12:00 AM EDT) -- A district court has banned the federal drug agency from granting new applications by generic drug makers to market cheap copies of Pfizer’s popular Norvasc until it hears Mylan Laboratories’ case for six months’ exclusivity.

Mylan filed an emergency application for a temporary restraining order banning the U.S. Food and Drug Administration from issuing approvals to its competitors for any new ANDAs for amlodipine besylate tablets, the generic version of the blockbuster blood pressure medication, until its exclusive period expires on September 23.

The pharmaceutical company...
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