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Aurobindo Pharma gets USFDA approval for CNS drug

Aurobindo Pharma gets USFDA approval for CNS drug
PTI
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First Published: Mon, Apr 25 2011. 01 21 PM IST
Updated: Mon, Apr 25 2011. 01 21 PM IST
New Delhi: Aurobindo Pharma on Monday 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 (USFDA), 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 $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 on Monday trading at Rs197.55 on the Bombay Stock Exchange (BSE) in the late afternoon trade, up 1.28% from its previous close.
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First Published: Mon, Apr 25 2011. 01 21 PM IST
More Topics: Aurobindo Pharma | USFDA | CNS drug | Medicine | Shares |