PITTSBURGH, Dec. 18, 2012 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Quinine Sulfate Capsules USP, 324 mg. This product is the generic version of Mutual Pharmaceutical Company, Inc.'s Qualaquin® Capsules, and is an antimalarial drug indicated only for treatment of uncomplicated Plasmodium falciparum malaria.(1)
Quinine Sulfate Capsules USP, 324 mg, had U.S. sales of approximately $31.9 million for the 12 months ending Sept. 30, 2012, according to IMS Health. Mylan has begun shipping this product.
Currently, Mylan has 178 ANDAs pending FDA approval representing $79.2 billion in annual sales, according to IMS Health. Thirty-five of these pending ANDAs are potential first-to-file opportunities, representing $21.2 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. See inside. mylan.com
(1) Quinine Sulfate Capsules are not approved for the treatment or prevention of nocturnal leg cramps and use for such treatment may result in serious and life-threatening hematologic reactions, including thrombocytopenia and hemolytic uremic syndrome/thrombotic thrombocytopenic purpura (HUS/TTP). Chronic renal impairment associated with the development of TTP has been reported.
SOURCE Mylan Inc.