DC Appeals Court Sides With FDA In Mylan's Patent Challenge For Duragesic

Law360, New York (August 19, 2004, 12:00 AM EDT) -- A federal judge has ruled that the U.S. Food and Drug Administration (FDA) acted appropriately in withdrawing its final approval of Mylan Laboratories's Abbreviated New Drug Application (ANDA) for its generic version of Alza Corp.’s Duragesic, a painkiller delivered to the skin through a patch.

Mylan had asked a judge in the U.S. District Court for the District of Columbia to grant a preliminary injunction and a declaratory judgment enjoining the FDA from revoking its final approval of Mylan’s ANDA and from applying Alza Corporation’s pediatric...
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