New Delhi: Aurobindo Pharma on Thursday said it has received the US health regulator’s nod to manufacture and market Fosinopril Sodium tablets, used for the treatment of hypertension, in the American market.
The approval from the United States Food and Drug Administration (USFDA) is for Fosinopril Sodium tablets USP in strengths of 10 mg, 20 mg and 40 mg, Aurobindo Pharma said in a filing to the Bombay Stock Exchange (BSE).
“The product has a market size of approximately $20 million for the twelve months ending September, 2010, according to IMS, and will be launched shortly,” the company said.
The tablets are generic versions of the Monopril tablets of global biopharmaceutical company Bristol-Myers Squibb in the same strengths and fall under the cardiovascular (CVS) therapeutic category.
Shares of Aurobindo Pharma were being quoted at Rs193.65 apiece in afternoon trade on the BSE on Thursday, down 0.08% from their previous close.