FDA tentatively approves Mylan generic hypertension drug

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Mylan has reported that its subsidiary, Mylan Pharmaceuticals, has received tentative approval from the 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 tablets, which had U.S. sales of approximately $288 million for the 12 months ending March 31, according to IMS Health.

Currently, the Pittsburgh-based Mylan has 92 ANDAs pending FDA approval, 20 of which are potential first-to-file opportunities.