A district court Thursday threw out Mylan’s attempt to gain 180-day exclusivity for generic versions of Novartis’ high blood pressure drug Diovan, saying the FDA properly granted the marketing perks to Ranbaxy. Mylan had asked the U.S. District Court for the District of Columbia to rule that the FDA erred when it decided Ranbaxy had not forfeited its 180-day exclusivity and order the agency to grant final approval to Mylan’s valsartan ANDA.
Drug Industry Daily