Mylan has announced that its subsidiary, Mylan Pharmaceuticals, has received tentative approval from the FDA for its abbreviated new drug application for Linezolid tablets, 600mg.
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Linezolid tablets, an antibiotic, are the generic version of Pharmacia and Upjohn’s Zyvox tablets.
Currently, Mylan has 93 abbreviated new drug applications pending FDA approval, 21 of which are potential first-to-file opportunities.
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