Mylan (MYL) Launches Generic Diovan HCT Tabs in U.S.

September 21, 2012 10:50 AM EDT
Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Valsartan and Hydrochlorothiazide Tablets USP, 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg and 320/25 mg. This product is the generic version of Novartis' (NYSE: NVS) Diovan HCT Tablets, which are indicated for the treatment of hypertension, to lower blood pressure in patients not adequately controlled with monotherapy or as initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals.(

Valsartan and Hydrochlorothiazide Tablets USP, 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg and 320/25 mg, had U.S. sales of approximately $1.6 billion for the 12 months ending June 30, 2012, according to IMS Health. Mylan is shipping this product immediately.


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