PITTSBURGH, Jan. 23, 2014 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that its U.S.-based subsidiary Mylan Pharmaceuticals Inc. has launched Repaglinide Tablets, 0.5 mg, 1 mg and 2 mg. This product is the generic version of Novo Nordisk's Prandin®, which is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.(1) The company received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product.
Repaglinide Tablets, 0.5 mg, 1 mg and 2 mg, had U.S. sales of approximately $212.95 million for the 12 months ending Sept. 30, 2013, according to IMS Health.
Currently, Mylan has 187 ANDAs pending FDA approval representing $93.7 billion in annual sales, according to IMS Health. Forty-one of these pending ANDAs are potential first-to-file opportunities, representing $24.1 billion in annual brand sales, for the 12 months ending June 30, 2013, according to IMS Health. When including ANDAs associated with Mylan's recent acquisition of Agila, the company now has a total of 287 ANDAs pending FDA approval.
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 excellence 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 1,200 generic pharmaceuticals and several brand medications. In addition, we offer a wide range of antiretroviral therapies, upon which approximately 40% 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 140 countries and territories. Our workforce of more than 20,000 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) Repaglinide tablets are not indicated for patients with diabetic ketoacidosis or Type 1 diabetes. It should not be used with gemfibrozil, NPH-insulin or in patients with a known hypersensitivity to the drug.
SOURCE Mylan Inc.