Mylan Sues FDA Over Exclusivity on Diovan Generics

Mylan is suing the FDA over its refusal to grant 180-day exclusivity for the company’s four generic versions of Novartis’ high blood pressure drug Diovan. Mylan claims that Ranbaxy, which was the first to file an ANDA for Diovan (valsartan), forfeited its 180-day exclusivity when it failed to win approval within 30 months of filing.
Washington Drug Letter