Novartis Loses Bid to Block FDA’s Approval of Generic Entresto

Aug. 14, 2024, 6:57 PM UTC

Novartis AG hasn’t shown that it is likely to suffer irreparable harm that entitles the drugmaker to a preliminary injunction of the FDA’s approval of a generic version of its heart failure drug, a federal court ruled.

Judge Dabney L. Friedrich of the US District Court for the District of Columbia on Tuesday denied Novartis’ motion for a temporary restraining order or preliminary injunction without prejudice against the Food and Drug Administration’s approval of a rival to Entresto by MSN Laboratories.

“Novartis advances three theories of irreparable harm, but none of them rise to such imminence and severity as to ...

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