Mylan Inc. 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.
Mylan is a global pharmaceutical company committed to setting new standards
in health care. Working together around the world to provide 7 billion people
access to high quality medicine, we innovate to satisfy unmet needs; make
reliability and service a habit, do what's right, not what's easy and impact
the future through passionate global leadership. We offer a growing portfolio
of more than 1,100 generic pharmaceuticals and several brand medications. In
addition, we offer a wide range of antiretroviral therapies, upon which
approximately one-third of HIV/AIDS patients in developing countries depend. We also operate one of the largest active pharmaceutical
ingredient manufacturers and currently market products in approximately 150
countries and territories. Our workforce of more than 18,000 people is
dedicated to improving the customer experience and increasing pharmaceutical
access to consumers around the world. But don't take our word for it. See for
yourself.
(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.