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FDA approves generic version of Actos

Mylan announces launch of generic Actos, Actoplus Met

SILVER SPRING, Md. — The Food and Drug Administration has approved the first generic version of a diabetes drug made by Takeda, the agency said Friday.

The FDA announced the approval of Mylan's pioglitazone hydrochloride tablets in the 15-mg, 30-mg and 45-mg strengths. The drug is a generic version of Takeda's Actos. Mylan announced its launch of the drug at the same time as the FDA's announcement, also announcing the launch of its previously approved generic version of Actoplus Met (pioglitazone hydrochloride and metformin) tablets in the 15-mg/500-mg and 15-mg/850-mg strengths.

Actos had sales of $2.7 billion during the 12-month period ended in June, according to IMS Health. Versions of Actoplus Met had sales of about $413 million during the same period.


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