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      Ranbaxy Gets USFDA Nod for Gabapentin

      Posted AtNew Kerala

      Mohali-based pharma major Ranbaxy Laboratories has recevied the final approval from US Food and Drug Administration (USFDA) for manufacturing and marketing Gabapentin capsules of 100, 300 and 400 mg.

      Ranbaxy informed BSE today "The office of generic drugs, USFDA, has determined Ranbaxy formulations to be bio-equivalent and have the same therapeutic effect as that of the reference listed drug Neurontin capsules of Pfizer."Gabapentin is prescribed for the management of postherpetic neuralgia in adults, and as adjunctive therapy in the treatment of partial seizures with and without secondary generalisation in patients over 12 years of age with epilepsy. It is also prescribed as adjunctive therapy in the treatment of partial seizures in pediatric patients of age 3-12 years, the company release said.

      October 10, 2005


       

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