Mylan Inc. 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' 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.(1)
Mylan CEO Heather Bresch commented: "Mylan's launch of the first generic Valsartan and Hydrochlorothiazide Tablets USP represents our eighth first-to-file launch this year, demonstrating our continued leadership in bringing new generic products to the market. 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."
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.
Currently, Mylan has 168 ANDAs pending FDA approval representing $77.8 billion in annual sales, according to IMS Health. Thirty-three of these pending ANDAs are potential first-to-file opportunities, representing $20.8 billion in annual brand sales, for the 12 months ending June 30, 2012, according to IMS Health.
(1) Valsartan and Hydrochlorothiazide Tablets can cause injury and death to the developing fetus and therefore should be discontinued if pregnancy occurs. It should also not be used in people who are allergic to any component of the product or to other sulfonamide-derived drugs. Other precautions include: excessive reductions in blood pressure, decreased renal function, allergic reactions, exacerbation or activation of systemic lupus erythematosus, drug interactions with lithium, potassium and electrolyte abnormalities, visual changes and metabolic disturbances. If any of these conditions occur or are suspected, medical attention should be sought.
SOURCE Mylan Inc.
Posted: September 2012