Mylan Pharmaceuticals, a subsidiary of Mylan, has received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Valsartan and Hydrochlorothiazide Tablets USP.
The product is the generic version of Novartis’ Diovan HCT tablets designed to treat hypertension in patients uncontrolled with monotherapy or as primary therapy in patients likely to be administered with multiple drugs to control blood pressure.
Mylan CEO Heather Bresch said Mylan’s launch of the first generic Valsartan and Hydrochlorothiazide Tablets USP represents its eighth first-to-file launch in the year.
”Through this launch, we are proud to continue contributing to the increased health care savings experienced by patients, governments and payors in the U.S. supported by the generic availability of an important, widely prescribed product such as this one,” Bresch added.
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 nearly $1.6bn for the 12 months ending June 30, 2012 in US, according to IMS Health.
Valsartan and Hydrochlorothiazide Tablets are not suggestable to pregnant women and people allergetic to component of the product or to other sulfonamide-derived drugs.