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FDA Grants Alpharma (ALO) Final Approval And First-To-File Status For Gabapentin Tablets



10/19/2005 5:11:54 PM

FORT LEE, N.J., Oct. 22 /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 tablets, 600 mg and 800 mg. The FDA also awarded the company first-to-file status and 180-day market exclusivity for these tablets. Alpharma's gabapentin tablets, to be marketed under the Purepac® brand, are the generic equivalent of Neurontin® brand tablets, marketed by Pfizer. Neurontin® tablets had brand sales of over $700 million in 2003 and is indicated as adjunctive therapy in the treatment of partial seizures of epilepsy and post-herpetic neuralgia. The company is not commenting on launch plans at this time.

Neurontin ® is a registered trademark of the Warner Lambert Company.

Alpharma press releases are also available at our website: http://www.alpharma.com.

Alpharma Inc. (NYSE: ALO - News) is a global generic pharmaceutical company with leadership positions in products for humans and animals. Uniquely positioned to expand internationally, Alpharma is presently active in more than 60 countries. Alpharma is a leading manufacturer of generic pharmaceutical products in the U.S., offering solid, liquid and topical pharmaceuticals. It is also one of the largest suppliers of generic solid dose pharmaceuticals in Europe, with a growing presence in Southeast Asia. Alpharma is among the world's leading producers of several important pharmaceutical-grade bulk antibiotics and is internationally recognized as a leading provider of pharmaceutical products for poultry, swine and cattle.

Source: Alpharma Inc.


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