US generics major Mylan (Nasdaq: MYL) says it has launched voriconazole for oral suspension, 40mg/mL, which is the first generic version of pharma behemoth Pfizer's (NYSE: PFE) Vfend, a triazole antifungal drug.
Mylan says it was the first company to have filed a substantially complete Abbreviated New Drug Application containing a Paragraph IV patent certification for voriconazole for oral suspension, 40mg/mL. The company received final approval from the US Food and Drug Administration for its ANDA for this product and was awarded 180 days of marketing exclusivity.
Mylan chief executive Heather Bresch commented: "Mylan's launch of voriconazole for oral suspension, 40mg/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."
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