Generic Drug Maker Ranbaxy gets US nod for new Drug

10 October, 2005

Ranbaxy Laboratories Ltd. (RLL) has received final approval from US Food & Drug Administration (US FDA) for manufacturing and marketing multiple doses of Gabapentin capsules. The approval permits RLL to manufacture and market the medicine in multiple doses of 100 mg, 300 mg and 400 mg, the company informed the Bombay Stock Exchange on Monday.

The Office of Generic Drugs, US FDA, found Ranbaxy's formulations to be bioequivalent, having the same therapeutic effect as that of the reference listed drug, Pfizer's Neurontin Capsules. Gabapentin is indicated for the management of postherpetic neuralgia in adults.

The medicine is also indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in epilepsy patients aged 12 and above. It treats partial seizures in pediatric patients aged between 3-12 years as well.

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