The Hindu Business Line : Ranbaxy gets tentative nod from FDA for Gabapentin

RANBAXY Laboratories Ltd has received a tentative approval from the US Food & Drug Administration for generic anti-depressant, Gabapentin, in capsule form.

According to the FDA, the approval is for "oral capsules" in 100 milligram, 300 mg and 400 mg strengths.

Gabapentin is the generic name of US drug company Pfizer Inc's Neurontin. The total market sales for Gabapentin capsules were at $1.7 billion annually as on June 2004, Ranbaxy said.

A tentative approval letter is issued from the FDA to an applicant when all scientific and procedural conditions are met; however the approval has a delayed effective date usually because product marketing is blocked by some form of marketing exclusivity, according to the US FDA Web site.

An approval with a delayed effective date does not become final until the FDA issues an approval letter. A tentative approval does not allow the applicant to market the generic drug product.

Gabapentin is indicated for the management of "postherpetic neuralgia" in adults, according to a Ranbaxy statement.

It 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 aged 3-12 years, it adds.

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