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FDA Grants Final Approval for Gabapentin Capsules

FORT LEE, N.J., Sept. 12 /PRNewswire-FirstCall/ -- Alpharma Inc. today announced that Purepac Pharmaceutical Co., a subsidiary of Alpharma, has received final approval from the United States Food and Drug Administration (FDA) for gabapentin capsules, 100 mg, 300 mg, and 400 mg.

In January 2003, Alpharma announced that Purepac Pharmaceutical Co. received confirmation from the FDA that it was eligible for 180-day market exclusivity on gabapentin 100 mg, 300 mg and 400 mg capsules. The company also previously announced that the FDA's position on exclusivity is being challenged by Torpharm, Inc. The Torpharm action is presently before the U.S. Court of Appeals for the District of Columbia based upon a ruling by the District Court upholding the FDA's exclusivity determination. Unless the Court of Appeals should hold in favor of Torpharm, Purepac's exclusivity for this product will be triggered by the earlier of either Purepac's commercial marketing of gabapentin or a court decision holding the relevant Pfizer gabapentin patent invalid or not infringed. The company has not yet received a trial date in the litigation with Pfizer regarding gabapentin and has not announced a launch date for this product.

While the January 2003 FDA ruling on capsules did not address the tablet form of gabapentin, the company expects the FDA position on market exclusivity for the 600 mg and 800 mg gabapentin tablets to be consistent with its position on capsules.

Alpharma's gabapentin capsules, to be marketed under the Purepac(R) brand, are the generic equivalent of Neurontin(R) brand capsules, marketed by Pfizer. Neurontin(R) capsules and tablets have annual brand sales of over $2 billion and is indicated as adjunctive therapy in the treatment of partial seizures of epilepsy and post-herpetic neuralgia.

Source: Alpharma Inc.

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