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Pioglitozone tablets approval for Mylan Pharmaceuticals.

M2 EQUITYBITES-August 20, 2012-Pioglitozone tablets approval for Mylan Pharmaceuticals(C)2012 M2 COMMUNICATIONS

Mylan Pharmaceuticals (NASDAQ:MYL), a Pennsylvania-based generic and speciality pharmaceuticals company, has acquired FDA approval in the US for its abbreviated new drug application for Pioglitazone tablets USP 15mg, 30mg and 45mg, it was reported today.

The FDA had already approved the company's application for Pioglitazone Hydrochloride and Metformin Hydrochloride Tablets, 15mg/500mg and 15mg/850mg. Mylan has been granted 180 days of generic marketing exclusivity by the FDA on both products, which are versions of Takeda's Actos Tablets and Actoplus Met Tablets, respectively. These are recommended in addition to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Figures from IMS Health indicated that Pioglitazone Tablets USP, 15mg, 30mg and 45mg, and Pioglitazone Hydrochloride and Metformin Hydrochloride Tablets, 15mg/500mg and 15mg/850mg, achieved US sales of approximately USD2.7bn and USD413m respectively for the twelve months ending 30 June 2012.

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Publication:M2 EquityBites (EQB)
Date:Aug 20, 2012
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