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Appeals Court Orders FDA To Stay ANDA Approval For Neurontin Generic Capsules

Law360 (July 28, 2004, 12:00 AM EDT) -- A federal appeals court has ordered the U.S. Food and Drug Administration to stay final approval of the Alpharma’s generic version of Pfizer's epilepsy treatment Neurontin pending an appeal.

The U.S. Court of Appeals for the District of Columbia ordered the FDA to stay final approval for Alpharma's Abbreviated New Drug Application (ANDA) for gabapentin capsules be stayed pending a resolution of the appeal of litigation brought by Canadian generics maker Apotex, Inc.

Apotex has challenged Alpharma's entitlement to 180-day marketing exclusivity for these capsules. The...
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