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news.Mylan has announced that its subsidiary, Mylan Pharmaceuticals, has received tentative approval from the FDA for its abbreviated new drug application for Irbesartan and hydrochlorothiazide tablets, 150mg/12.5mg and 300mg/12.5mg.
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Irbesartan and hydrochlorothiazide tablets, indicated for the treatment of hypertension, are the generic version of Sanofi Aventis’s Avalide tablets.
Currently, Mylan has 92 abbreviated new drug applications pending FDA approval, 20 of which are potential first-to-file opportunities.