FDA Urges Court to Deny Novartis Generic Drug Approval Suit

The FDA is urging a federal court to reject Novartis’ motion for preliminary injunction in a challenge against the agency’s approval of a generic version of the manufacturer’s heart failure medicine.

Novartis AG “has no legitimate interest in enjoining FDA’s lawful actions or blocking competition from a lawfully approved generic drug,” the Food and Drug Administration said Tuesday to the US District Court for the District of Columbia.

The agency’s opposition comes after Novartis alleged the FDA unlawfully approved a generic version of its heart failure drug, Entresto. The drugmaker filed the lawsuit nearly a week after the FDA approved ...