Final FDA OK for Mylan's generic of B-MS' Metaglip

22 April 2007

Generic drugmaker Mylan Pharmaceuticals has received final approval from the US Food and Drug Administration for its Abbreviated New Drug Application for glipizide and metformin HCl tablets in 2.5mg/250 mg, 2.5mg/500mg and 5mg/500mg strengths.

This is the generic version of Bristol-Myers Squibb's Metaglip, which generated US sales of around $29.0 million for the same strengths during the 12-month period ended December 31, 2006, according to IMS Health.

Announcing the news on April 13, Mylan said it will start shipping the product immediately.

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