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Generic Neurontin Gains Approval

PRINCETON, N.J., Oct. 11 /PRNewswire/ -- Ranbaxy Pharmaceuticals Inc. (RPI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), announced today that RLL has received final approval from the U.S. Food and Drug Administration to manufacture and market Gabapentin Capsules, 100 mg, 300 mg, and 400 mg. The Office of Generic Drugs, U.S. Food and Drug Administration, has determined the Ranbaxy formulations to be bioequivalent and have the same therapeutic effect as that of the reference listed drug Neurontin Capsules(R) by Pfizer, Inc. Total market sales for oral Gabapentin was $2.2 billion with sales of Gabapentin Capsules totaling $1.2 billion (IMS - MAT: June 2005).

Gabapentin is indicated for the management of postherpetic neuralgia in adults. Gabapentin is also indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in patients over 12 years of age with epilepsy and is also indicated as adjunctive therapy in the treatment of partial seizures in pediatric patients age 3 - 12 years.

According to Venkat Krishnan, Vice President, Ranbaxy Inc., "We are delighted to receive final approval for Gabapentin. This product demonstrates Ranbaxy's capabilities to formulate multiple oral product dosage forms." Commenting on the approval, Jim Meehan, Vice President of Sales and Marketing for RPI, stated, "We will launch product immediately and will now be in a position to offer both dosage forms in our product portfolio."

Source: Ranbaxy Pharmaceuticals Inc.

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