PITTSBURGH today announced that 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.
Mylan CEO Heather Bresch commented: "Mylan's immediate launch of these products is representative of the company's ongoing commitment to expand access to high quality, more affordable medicines. A crucial part of setting new standards in health care includes meeting patients' unmet needs, and we look forward to continuing to grow our portfolio of products for patients living with diabetes."
Pioglitazone Tablets USP, 15 mg, 30 mg and 45 mg, had U.S. sales of approximately $2.7 billion, and Pioglitazone Hydrochloride and Metformin Hydrochloride Tablets, 15 mg/500 mg and 15 mg/850 mg, had U.S. sales of approximately $413 million for the 12 months ending June 30, 2012, according to IMS Health.
Currently, Mylan has 166 ANDAs pending FDA approval representing $75.6 billion in annual sales, according to IMS Health. Thirty-four of these pending ANDAs are potential first-to-file opportunities, representing $21.7 billion in annual brand sales, for the 12 months ending Dec. 31, 2011, according to IMS Health.
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