PITTSBURGH, May 15, 2013 /PRNewswire/ -- Mylan Inc. (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 Zolmitriptan Tablets, 2.5 mg and 5 mg. This product is the generic version of IPR Pharmaceuticals Inc.'s Zomig® Tablets and is indicated for the acute treatment of migraine with or without aura in adults. Zolmitriptan Tablets are for use only where a clear diagnosis of migraine has been established. If a patient does not respond after the first dose, a healthcare provider should reconsider the diagnosis before re-administering. The product is not indicated for the prevention of migraine attacks or cluster headaches.
Zolmitriptan Tablets, 2.5 mg and 5 mg, had U.S. sales of approximately $152.8 million for the 12 months ending March 31, 2013, according to IMS Health. Mylan has begun shipping this product.
Currently, Mylan has 178 ANDAs pending FDA approval representing $83.1 billion in annual sales, according to IMS Health. Thirty-four of these pending ANDAs are potential first-to-file opportunities, representing $22.4 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 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 approximately 1,100 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