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Tentative FDA nod for Ranbaxy's anti-depressant

Our Bureau

New Delhi, Aug. 26

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

A tentative approval letter is issued from 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, explains the US FDA Web site.

An approval with a delayed effective date does not become final until FDA issues an approval letter, it adds.

According to 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 drug, whose sales were estimated at $2.4 billion in 2003.

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