Mylan Inc. today announced that its subsidiary, Mylan Pharmaceuticals Inc., has received tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Linezolid Tablets, 600 mg.
Linezolid Tablets, an antibiotic, are the generic version of Pharmacia and Upjohn's Zyvox(R) Tablets, which had U.S. sales of approximately $422 million for the 12 months ending March 31, 2008, according to IMS Health.
Currently, Mylan has 93 ANDAs pending FDA approval, 21 of which are potential first-to-file opportunities.
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