Published on September 30, 2013 at 8:39 AM
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.
SOURCE Mylan Inc.