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PITTSBURGH — Mylan Pharmaceuticals Inc. has launched voriconazole for oral suspension (40 mg/ml), an antifungal medicine.
Mylan said Monday that its product is the first generic version of Pfizer’s Vfend for Oral Suspension.
Voriconazole for oral suspension (40 mg/ml), a triazole antifungal drug, had U.S. sales of about $17.1 million for the 12 months ended June 30, according to IMS Health data reported by Mylan.
Mylan noted that it was was the first company to have filed a substantially complete Abbreviated New Drug Application (ANDA) containing a Paragraph IV patent certification for voriconazole for oral suspension (40 mg/ml) and, after receiving final approval from the Food and Drug Administration, was awarded 180 days of marketing exclusivity.
"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," stated Mylan chief executive officer Heather Bresch. "We are committed to continuing to develop, manufacture and market a broad range of generic pharmaceuticals, including specialty, niche products such as this one."
