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