Aurobindo Pharma has received tentative approval from the US Food and Drug Administration (US FDA) for Pioglitazone Hydrochloride and Metformin hydrochloride tablets, 15mg (base)/500mg and 15mg (base)/850mg (ANDA 200823). The product will be eligible for final approval upon the expiration of 180-day generic drug exclusivity.
Pioglitazone hydrochloride and metformin hydrochloride tablets, 15mg (base)/500mg and 15mg (base)/850mg are the generic equivalent of Takeda Global Research Development Center Inc’s actoplus met tablets, 15mg (base)/500mg and 15mg (base)/850mg. Pioglitazone Hydrochloride and metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type II diabetes mellitus when treatment with both pioglitazone and metformin is appropriate. The product has a market size of approximately $433 million for the 12 months ending March 2012 according to IMS.
The product has been approved out of unit VII (SEZ) formulations facility in Hyderabad. Aurobindo now has a total of 159 ANDA approvals (134 final approvals including 1 from Aurolife Pharma LLC and 25 tentative approvals) from US FDA.
EP News Bureau