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FDA approves Aurobindo diabetes drug

Generic pioglitazone tablets approved in 15 mg, 30 mg, 45 mg strengths

HYDERABAD, India — The Food and Drug Administration has approved a generic diabetes drug made by Aurobindo Pharma, the drug maker said.

Aurobindo announced the approval of pioglitazone tablets in the 15 mg, 30 mg and 45 mg strengths, in addition to the earlier tentative approval it received for pioglitazone and metformin hydrochloride tablets in the 15 mg/500 mg and 15 mg/850 mg strengths.

Pioglitazone tablets are a generic version of Takeda's Actos, while pioglitazone and metformin hydrochloride tablets are a generic version of Takeda's Actoplus Met. The products had combined sales of $2.8 billion in the 12-month period ending in September 2012, according to IMS Health.


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