Mylan Pharmaceuticals, a subsidiary of Mylan, has introduced Voriconazole for oral suspension, 40 mg/mL, which is the first generic version of Pfizer's VFEND for oral suspension.
The US Food and Drug Administration (FDA) has granted a final clearance for Mylan's abbreviated new drug application (ANDA) for Voriconazole, a triazole antifungal drug, and awarded 180 days of marketing exclusivity to the company.
It is reportedly the first company to file a substantially complete ANDA containing a Paragraph IV patent certification for Voriconazole with the FDA.
Mylan CEO Heather Bresch said 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," Bresch added.
Mylan currently has 178 ANDAs pending FDA approval, out of which 42 pending ANDAs are potential first-to-file opportunities.
