MSN Laboratories’ US Food and Drug Administration approval for its generic version of Novartis’ multi-billion-dollar Entresto (sacubitril/valsartan) heart failure powerhouse has been stayed for now by an appeals court in Washington D.C., in the latest twist in the firms’ complex, ongoing litigation.
The Indian firm won approval for its Entresto generic in late July in the wake of the agency denying a pair of Novartis Entresto citizen petitions – one concerning the “same active