Aurobindo Pharma has received final approvals from the US Food & Drug Administration (US FDA) to manufacture and market Pioglitazone tablets USP 15 mg, 30 mg and 45 mg (ANDA 200268) and its earlier tentatively approved Pioglitazone Hydrochloride + Metformin Hydrochloride tablets, 15 mg(base)/500 mg and 15 mg(base)/850 mg (ANDA 200823). The products are ready for launch.
Pioglitazone tablets USP 15 mg, 30 mg, 45 mg and Pioglitazone Hydrochloride + Metformin Hydrochloride tablets, 15 mg(base)/500 mg, 15 mg(base)/850 mg are the generic equivalents of Takeda Global Research Development Center’s Actos tablets 15 mg, 30 mg, 45 mg and Actoplus Met tablets, 15 mg (base)/500 mg, 15 mg (base)/850 mg respectively. The products are indicated as an adjunct to diet and exercise to improve glycemic control in adults with Type-II diabetes mellitus.
The combined market size of the products is approximately $2.8 billion for the 12 months ending September 2012 according to IMS. Aurobindo Pharma now has a total of 177 ANDA approvals (152 Final approvals including 2 from Aurolife Pharma and 25 tentative approvals) from US FDA.
EP News Bureau – Mumbai