Novartis Loses Appeal Over FDA Approval of Generic Heart Drug

Novartis AG failed to prove that the FDA unlawfully approved a generic version of its heart failure drug Entresto, a federal appeals court ruled Friday.

The drugmaker’s claim that the Food and Drug Administration unlawfully approved copies of MSN Laboratories’ drug because the generic version lacked critical safety information on its labeling didn’t convince the US Court of Appeals for the District of Columbia Circuit.

“We are not persuaded,” Judge Gregory Katsas wrote in the opinion for the court. “For one thing, longstanding FDA regulations and guidance make clear that drugs can have the same active ingredients even if they ...