Mylan Launches First Generic VFEND® for Oral Suspension - Company awarded 180 days marketing exclusivity -
PITTSBURGH, Sept. 30, 2013 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. has launched Voriconazole for Oral Suspension, 40 mg/mL, which is the first generic version of Pfizer's VFEND® for Oral Suspension. Mylan was the first company to have filed a substantially complete ANDA containing a Paragraph IV patent certification for Voriconazole for Oral Suspension, 40 mg/mL. The company received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product and was awarded 180 days of marketing exclusivity.
Mylan CEO Heather Bresch commented: "Mylan's launch of Voriconazole for Oral Suspension, 40 mg/mL, supports the company's mission to expand access to high quality medicine by bringing to market the first, low-cost generic version of this product. We are committed to continuing to develop, manufacture and market a broad range of generic pharmaceuticals, including specialty, niche products such as this one."
Voriconazole for Oral Suspension, 40mg/mL, is a triazole antifungal drug and, according to IMS Health, had U.S. sales of approximately $17.1 million for the 12 months ending June 30, 2013.
Currently, Mylan has 178 ANDAs pending FDA approval representing $83.8 billion in annual sales, according to IMS Health. Forty-two of these pending ANDAs are potential first-to-file opportunities, representing $23.8 billion in annual brand sales, for the 12 months ending Dec. 31, 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
SOURCE Mylan Inc.