Mylan Launches Generic Actoplus Met® Tablets and Generic Actos® Tablets
-Company granted 180 days marketing exclusivity on both products-
PITTSBURGH, Aug. 17, 2012 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Pioglitazone Tablets USP, 15 mg, 30 mg and 45 mg. Previously, the company 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.(1) The FDA has awarded Mylan 180 days of generic marketing exclusivity on both of these products.
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