Mylan Pharmaceuticals has won final FDA approval for its abbreviated new drug application (ANDA) for Pioglitazone tablets USP, 15mg, 30mg and 45mg.
Previously, FDA has also approved the company's ANDA for Pioglitazone Hydrochloride and Metformin Hydrochloride Tablets, 15mg/500mg and 15mg/850mg.
The FDA has granted Mylan 180 days of generic marketing exclusivity on both the products that are versions of Takeda's Actos Tablets and Actoplus Met Tablets, respectively, and are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Mylan CEO Heather Bresch said, "Mylan's immediate launch of these products is representative of the company's ongoing commitment to expand access to high quality, more affordable medicines."
According to IMS Health, for the twelve months ending 30 June 2012 Pioglitazone Tablets USP, 15mg, 30mg and 45mg, had US sales of approximately $2.7bn, and Pioglitazone Hydrochloride and Metformin Hydrochloride Tablets, 15mg/500mg and 15mg/850mg, had US sales of approximately $413m.
