Aurobindo Pharma gets USFDA nod for Gabapentin tablets

New Delhi, Oct 11 : Drug firm Aurobindo Pharma today said it has received final approval from USFDA to manufacture and market generic Gabapentin tablets, used in the treatment of central nervous system (CNS) disorders.

"Aurobindo Pharma has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Gabapentin tablets USP 600 mg and 800 mg in the American market," the company said in a statement.

Gabapentin tablets are the generic equivalent of the Neurontin tablets of Pfizer Pharmaceuticals.

According to IMS, the annual sales of Gabapentin tablets USP 600 mg and 800 mg in the US market were approximately 220 million dollar for the twelve months ending June, 2011, it said.

The company said it plans to launch the tablets soon in the US market.

The tablets are indicated for the treatment of partial seizures and other nervous system disorders.

At present, the company said, it has a total of 139 abbreviated new drug application (ANDA) approvals from USFDA. Out of these 110 are final approvals and 29 tentative approvals. (UNI -Posted on / )

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