Aurobindo Pharma gets USFDA approval for CNS drug

NEW DELHI: Aurobindo Pharma today said it has received US health regulator's approval to manufacture and sell generic Divalproex Sodium Delayed-Release tablets, used in the treatment of central nervous system disorders, in the American market.

The company, which has received final approval from US Food and Drug Administration, will soon launch the tablets in the strengths of 125mg, 250mg and 500mg in the US market, Aurobindo Pharma said in a statement.

According to IMS Health data, the product has a global market size of nearly USD 144 million for the twelve months ending September 2010.

The company's product is the generic equivalent of Abbott Laboratories' Depakote Delayed-Release Tablets and falls under the neurological (CNS) therapeutic category, it said.

The Hyderabad-based firm now has a total of 135 abbreviated new drug application (ANDA) approvals from USFDA, it added.

Shares of Aurobindo Pharma were today trading at Rs 197.55 on the Bombay Stock Exchange in the late afternoon trade, up 1.28 per cent from its previous close.