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Alpharma receives FDA approval for Gabapentin Tablets 600 mg and 800 mg
New Jersey | Saturday, August 3, 2002, 08:00 Hrs  [IST]

Purepac Pharmaceutical Co., a subsidiary of Alpharma, has received approvable status from the United States Food and Drug Administration (FDA) to manufacture and market gabapentin tablets 600mg and 800mg. Final approval is subject to the satisfactory resolution of certain regulatory and legal issues, including the company's ongoing litigation with Pfizer. The company received approvable status from the FDA on gabapentin capsules on May 8, 2002.

Alpharma's gabapentin tablets, to be marketed under the Purepac brand, are the generic equivalent of Neurontin brand tablets, marketed by Pfizer. Neurontin is indicated as adjunctive therapy in the treatment of partial seizures of epilepsy. Brand sales of Neurontin 600mg and 800mg tablets were approximately $400 million for the year-ended December 2001.

Neurontin is a registered trademark of the Warner Lambert Company.

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