Alpharma was notified that the United States Court of Appeals for the District of Columbia has ordered that the FDA final approval for Alpharma's gabapentin capsule ANDA be stayed pending a resolution of the appeal of previously announced litigation brought by Apotex Inc in which it challenged Alpharma's entitlement to 180 day exclusivity for these capsules.
The decision prevents any Alpharma launch of this product during the period the stay remains in effect, a release from Alpharma said.
Alpharma Inc is a specialty pharmaceutical company with expanding global leadership positions in products for humans and animals. Alpharma is presently active in more than 60 countries.