PITTSBURGH, May 29, 2012 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Laboratories Limited (formerly Matrix Laboratories Limited) has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Atorvastatin Calcium Tablets, 10 mg, 20 mg, 40 mg and 80 mg. Atorvastatin Calcium is the generic version of Pfizer's Lipitor® Tablets, which are indicated as an adjunct to diet in patients with primary hypercholesterolemia and mixed dyslipidemia to reduce elevated total cholesterol, LDL, triglycerides and to increase HDL cholesterol.
Mylan CEO Heather Bresch said: "We are very pleased to have received final approval for our ANDA for generic Lipitor®, the most widely prescribed drug in U.S. history. Through Mylan's launch of Atorvastatin Calcium Tablets, we look forward to be able to offer our customers, the American consumer and the U.S. government significant savings and expanded access to this important product."
Lipitor had U.S. sales of $8.1 billion for the twelve months ending March 31, 2012, according to IMS Health. Mylan is shipping this product immediately.
Currently, Mylan has 171 ANDAs pending FDA approval representing $84 billion in annual sales, according to IMS Health. Thirty-eight of these pending ANDAs are potential first-to-file opportunities, representing $25.5 billion in annual brand sales, for the 12 months ending Dec. 31, 2011, 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.