PITTSBURGH, Aug. 10, 2012 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today 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 Lithium Carbonate Extended-release Tablets USP, 450 mg. This product is indicated for the treatment of manic episodes of manic depressive illness.(1)
Lithium Carbonate Extended-release Tablets USP, 450 mg, had U.S. sales of approximately $15.2 million for the 12 months ending June 30, 2012, according to IMS Health. Mylan is launching this product immediately.
Currently, Mylan has 166 ANDAs pending FDA approval representing $78.4 billion in annual sales, according to IMS Health. Thirty-five of these pending ANDAs are potential first-to-file opportunities, representing $25.1 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.
(1) Lithium toxicity is closely related to serum lithium levels and can occur at doses close to therapeutic levels. Lithium carbonate may impair mental and/or physical abilities. Lithium should not be given to patients with significant renal or cardiovascular disease, severe debilitation or dehydration or sodium depletion, since the risk of lithium toxicity is very high in such patients.
SOURCE Mylan Inc.