Mylan Pharmaceuticals gets FDA nod for generic Actos

CANONSBURG, Pa.—The U.S. Food and DrugAdministration (FDA) on Aug. 17 approved the first generic version of Actos tablets, with that first-such-nod going to West Virginia-based Mylan Pharmaceuticals, a subsidiary of Mylan Inc. Pioglitazone is intended to be used along with diet and exercise toimprove blood glucose control in adults with type 2 diabetes.

Mylan gained FDA approval for pioglitazone hydrochloride and metformin hydrochloride Tablets, 15mg/500 mg and 15 mg/850 mg, which represent the generic versions of Takeda Pharmaceutical Co.'s Actos tablets and Actoplus Met tablets.

"Controlling blood sugar levels is very importantin preventing or reducing the long-term health complications of diabetes," saidDr. Gregory P. Geba, director of the Office of Generic Drugs in FDA'sCenter for Drug Evaluation and Research. "Generic versions of this widely usedproduct will offer affordable treatment options for patients who must managethis chronic and potentially serious condition."

"Mylan's immediate launch of these products isrepresentative of the company's ongoing commitment to expand access tohigh quality, more affordable medicines," said Mylan CEO Heather Bresch. "A crucial part of setting newstandards in healthcare includes meeting patients' unmet needs, and welook forward to continuing to grow our portfolio of products forpatients 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, 15mg/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.