Mylan cardiovascular news
A judge in the U.S. District Court for the District of Columbia heard and took under advisement a preliminary injunction sought by generic drug maker Mylan. Under an October complaint, Mylan is asking the court to enjoin FDA from awarding 180-day exclusivity for a generic version of valsartan to Ranbaxy Laboratories Ltd. (NSE:RANBAXY; BSE:500359, Gurgaon, India) and directing FDA to approve Mylan's generic immediately. In the suit, Mylan alleges that FDA's decision to grant exclusivity to Ranbaxy was arbitrary, capricious, an abuse of discretion and contrary to law. The suit also noted that Ranbaxy had forfeited eligibility for exclusivity after failing to obtain tentative approval for its generic valsartan within 30 months after the date on which the application for approval was filed. ...