Aurobindo Pharma gets USFDA approval for generic CNS drug

 Drug firm Aurobindo Pharma today said it has received final approval from the US health regulator to manufacture and market generic Gabapentin tablets, used in the treatment of central nervous system (CNS) disorders, in the American market.

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

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

The company plans to launch the tablets soon in the US market, Aurobindo Pharma said.

"The annual sales of Gabapentin tablets USP 600 mg and 800 mg in the US were approximately USD 220 million for the twelve months ending June, 2011, according to IMS," it added.

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

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

Shares of Aurobindo Pharma were trading at Rs 130.25 apiece in afternoon trade on the BSE today, up 2.56% from their previous close.