Novartis Wins Temporary Pause of FDA’s Entresto Generic Approval

A federal appeals court has ordered MSN Pharmaceuticals Inc. to pause the launch of its generic version of Novartis AG’s heart failure drug Entresto.

The US Court of Appeals for the District of Columbia Circuit issued Wednesday an administrative stay that temporarily pauses the Food and Drug Administration’s approval of MSN’s Entresto copy, as it considers a legal battle between the agency and Novartis.

The pharmaceutical giant challenged the FDA last year, alleging the agency unlawfully approved copies of its drug treating heart failure. A federal judge, however, rejected in October 2024 Novartis’ motion for summary judgment against the ...