Ranbaxy Laboratories Limited (RLL) has received tentative approval from the US Food and Drug Administration, Office of Generic Drugs, to manufacture and market Gabapentin Tablets, 600 and 800 mg strengths.
Earlier in August 2004, RLL had received tentative approval from the US FDA to manufacture and market Gabapentin Capsules, 100, 300 and 400 mg strengths. Total sales for Gabapentin were $2.8 billion with Gabapentin Tablets, 600 and 800 mg strengths, totalling $1.1 billion (+44%) - (IMS - MAT: September 2004), according to the release.
According to Jim Meehan, VP of Sales and Marketing for RPI, USA, "We are pleased to receive this tentative approval for Gabapentin Tablets. This product represents a future opportunity, and we will launch Gabapentin Tablets following final approval from the FDA."
Gabapentin (Neurontin) is 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 paediatric patients age 3 - 12 years.