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 Irbesartan and Hydrochlorothiazide Tablets, 150 mg/12.5 mg and 300 mg/12.5 mg.
Irbesartan and Hydrochlorothiazide Tablets, indicated for the treatment of hypertension, are the generic version of Sanofi Aventis' Avalide(R) Tablets, which had U.S. sales of approximately $288 million for the 12 months ending March 31, 2008, according to IMS Health.
Currently, Mylan has 92 ANDAs pending FDA approval, 20 of which are potential first-to-file opportunities.
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