Ranbaxy Laboratories Limited has received final approval from the US FDA to manufacture and market gabapentin capsules, 100 mg, 300 mg, and 400 mg. The Office of Generic Drugs, US FDA, has determined the Ranbaxy formulations to be bioequivalent and have the same therapeutic effect as that of the reference listed drug neurontin capsules by Pfizer Inc.
According to a company release, the total market sales for oral gabapentin was $2.2 billion with sales of gabapentin capsules totalling $1.2 billion.
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 generalisation 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.
Venkat Krishnan, vice president, Ranbaxy Inc., US, stated, "Gabapentin 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, US, said that the product would be launched immediately and would be in a position to offer both dosage forms in their product portfolio.