Aurobindo Pharma today said it has received US health regulator's approval to market
anti-diabetes drug Pioglitazone Tablets in the American market.
The drug firm has received approval from US Food and Drug Administration (USFDA) to manufacture and market Pioglitazone Tablets and its earlier tentatively approved combination of Pioglitazone Hydrochloride and Metformin Hydrochloride Tablets, Aurobindo Pharma said in a statement.
The products are ready for launch, it added.
The medicines are indicated as an addition to diet and exercise to improve glycemic control in adults with type-2 diabetes mellitus.
"The combined market size of the products is approximately $2.8 billion for the twelve months ending September 2012 according to IMS," the company said.
Aurobindo now has a total of 177 ANDA approvals (152 final approvals including 2 from Aurolife Pharma LLC and 25 tentative approvals) from USFDA, according to the release.
Shares of Aurobindo were trading at Rs 183.35 on the BSE in afternoon trade, up 1.24% from its previous close
