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# Court Tosses Novartis Entresto Suit Against FDA
- URL: https://www.fdaweb.com/court-tosses-novartis-entresto-suit-against-fda/
- Published: 2024-10-16T12:00:00.000Z
- Updated: 2026-09-14T14:44:08.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157997

The DC federal court has granted summary judgment to FDA and MSN Pharmaceuticals, the defendants in a [suit](https://www.fdaweb.com/novartis-sues-fda-to-reverse-generic-entresto-ok/) filed by Novartis claiming the agency violated the Administrative Procedure Act, the Federal Food, Drug, and Cosmetic Act, and its implementing regulations by approving an MSN application to market a generic form of Novartis’ heart failure drug Entresto. The court [held](https://ecf.dcd.uscourts.gov/cgi-bin/show%5Fpublic%5Fdoc?2024cv2234-68&ref=fdaweb.com) that MSN’s generic drug was consistent with FDA regulatory and statutory requirements that require a generic drug to have the same label and active ingredients as the reference-listed drug. It also held that FDA did not act arbitrarily by excluding part of Entresto’s dosing regimen from the MSN generic drug label.

In its decision, the court supported FDA’s actions in approving an indication carveout and a dosing regimen carveout. It also deferred to FDA’s factual determination that Entresto and the MSN generic contain the same two active ingredients—sacubitril sodium and valsartan disodium. “Because FDA’s determination that Entresto and MSN’s generic contain the same active ingredients was rational, carefully explained, and consistent with the record evidence, the court will not ‘unduly second-guess’ its ‘scientific judgment,’” the court said.