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Mylan Gets FDA OK for Glimepiride Tablets


Posted on 2005-11-29 12:16:00



Mylan Laboratories Inc.  today announced that Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Glimepiride Tablets, 1 mg, 2 mg, and 4 mg. Glimepiride Tablets are the AB-rated generic equivalent of Aventis Pharmaceuticals' Amaryl  Tablets, which had U.S. sales of approximately $348 million for the 12-month period ending June 30, 2005, according to IMS Health.