Aurobindo gets USFDA nod for a copy of diabetes drug Actos

Moneycontrol Bureau

Drug maker Aurobindo Pharma has got final approval from US Food and Drugs Administration (FDA) to manufacture and market Pioglitazone tablets in 15mg, 30mg and 45mg strength, and its earlier tentatively approved Pioglitazone Hydrochloride + Metformin Hydrochloride tablets in 15mg (base)/500mg and 15mg (base)/850mg strengths. The tablets are a generic version of Takeda Global Research Development Centre's Actos and Actoplus Met tablets. They are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type-2 diabetes. The combined market size of the products was about USD 2.8 billion for 12-months ended Sept 2012, Aurobindo Pharma said, citing IMS Health data. It now has 177 ANDA (abbreviated new drug application) approvals from the US FDA, which includes 152 final and 25 tentative approvals, the Hyderabad-based company added. Aurobindo Pharma shares were down 1 percent at Rs 179.30 on NSE in noon trade.