Mylan gets FDA OK for Glimepiride, a generic of blood-sugar lowering Amaryl for Type 2 diabetes

By E. Janene Geiss

Philadelphia, Nov. 29 - Mylan Pharmaceuticals Inc. said it received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Glimepiride tablets, the generic equivalent of Amaryl tablets to lower blood-sugar levels in Type 2 diabetes.

The company said it received approval for 1 mg, 2 mg and 4 mg doses of the AB-rated generic equivalent of the Sanofi-Aventis drug, which had U.S. sales of $348 million in fiscal year 2005 according to IMS Health, a company news release said.

Mylan Laboratories is a Canonsburg, Pa., pharmaceutical company with three principal subsidiaries, Mylan Pharmaceuticals Inc., Mylan Technologies Inc. and UDL Laboratories, Inc., which develop, license, manufacture, market and distribute generic and proprietary products.

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