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