Drug firm Aurobindo Pharma on Wednesday said it has received final approval from the US health regulator to manufacture and market tablets of Alprazolam, a central nervous system drug, in the American market.
The company has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Alprazolam extended-release tablets in strengths of 0.5 mg, 1 mg, 2 mg and 3mg, Aurobindo Pharma said in a filing to the Bombay Stock Exchange (BSE).
“The product has a market size of approximately $26.5 million for the twelve months ending September, 2010, according to IMS and will be launched soon,” the company added.
Alprazolam extended-release tablets are the generic equivalent of Xanax XR tablets. The tablets are indicated for treating panic disorders and fall under the central nervous system (CNS) segment, it said.
The Hyderabad-based firm now has a total of 137 ANDA approvals from the USFDA, it added. Shares of Aurobindo Pharma were being quoted at Rs 179.50 apiece on the BSE in late afternoon trade today, down 0.83 per cent from their previous close.