Mylan Inc. announced that its subsidiary, Mylan Pharmaceuticals Inc., has received tentative approval from the US 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 tablets, which had US 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.
Mylan Inc., with a presence in more than 90 countries, ranks among the leading diversified generic and specialty pharmaceutical companies in the world.