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Mylan Gets Final FDA Approval For Pioglitazone Tablets USP - Quick Facts

Mylan Inc. (MYL) announced that its subsidiary Mylan Pharmaceuticals has received final approval from the U.S. Food and Drug Administration or FDA for its Abbreviated New Drug Application or ANDA for Pioglitazone Tablets USP, 15 mg, 30 mg and 45 mg.

The company said that previously it had also received final approval from the FDA for its ANDA for Pioglitazone Hydrochloride and Metformin Hydrochloride Tablets, 15 mg/500 mg and 15 mg/850 mg.

These products are the generic versions of Takeda Pharmaceutical Company'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. The FDA has awarded Mylan 180 days of generic marketing exclusivity on both of these products.

Pioglitazone Tablets USP, 15 mg, 30 mg and 45 mg, had U.S. sales of about $2.7 billion, and Pioglitazone Hydrochloride and Metformin Hydrochloride Tablets, 15 mg/500 mg and 15 mg/850 mg, had U.S. sales of about $413 million for the 12 months ending June 30, 2012, according to IMS Health.

by RTT Staff Writer

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