FDA Approval of Rival to Novartis’ Entresto Stayed by Court

The FDA’s approval of a generic version of Novartis AG’s heart failure drug Entresto is now paused pending the resolution of an appeal before the DC Circuit

The US Court of of Appeals for the District of Columbia Circuit on Monday ordered that the Food and Drug Administration’s approval of an abbreviated new drug application for a generic version of Entresto, manufactured by MSN Laboratories, is stayed pending resolution of an appeal to the court filed by Novartis.

The emergency motion requesting an administrative stay and stay pending appeal came after a federal judge in Washington denied without prejudice Novartis’ ...