Pittsburgh, PA /PRNewswire/ - Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals has begun shipping Fenofibrate Capsules USP, 43 mg and 130 mg. This product is the generic version of Lupin Atlantis Holdings, S.A.'s Antara® Capsules, which are indicated as an adjunct to diet to reduce elevated LDL-C, Total-C, triglycerides, and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia and to reduce triglyceride levels in adult patients with severe hypertriglyceridemia. Fenofibrate has not been shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus.
Fenofibrate Capsules USP, 43 mg and 130 mg, had U.S. sales of approximately $60 million for the 12 months ending Sept. 30, 2012, according to IMS Health. Mylan has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product.
Currently, Mylan has 184 ANDAs pending FDA approval representing $80.7 billion in annual sales, according to IMS Health. Thirty-six of these pending ANDAs are potential first-to-file opportunities, representing $21.1 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
SOURCE: Mylan Inc.Copyright 2013 PR Newswire. All Rights Reserved