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Generic Version of Neurontin Approved by FDA

PRINCETON, N.J., Sept. 16 /PRNewswire/ -- Ranbaxy Pharmaceuticals Inc. (RPI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), announced today that RLL has received approval from the U.S. Food and Drug Administration, Office of Generic Drugs, to manufacture and market Gabapentin Tablets, 600 and 800 mg strengths. 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(R) of Pfizer Pharmaceuticals Inc. Total sales for Gabapentin were $2.2 billion with Gabapentin Tablets, 600 and 800 mg strengths, totaling $964 million (IMS - MAT: June 2005).

Gabapentin Tablets are indicated for the management of postherpetic neuralgia in adults. Gabapentin is 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 Jim Meehan, Vice President of Sales and Marketing for RPI, "We are pleased to receive this final approval for Gabapentin Tablets. We will now focus on maximizing the value of this formulation to the company that will have a positive impact on our performance for the balance of this year. Ranbaxy will begin shipping this affordable generic alternative immediately."

Source: Ranbaxy Pharmaceuticals Inc.

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