Novartis Loses Bid to Vacate FDA Approval of Rival Entresto (1)

Oct. 14, 2024, 4:39 PM UTCUpdated: Oct. 14, 2024, 8:56 PM UTC

A federal judge rejected Novartis Pharmaceuticals Corp.’s motion to declare as unlawful the FDA’s approval of a rival version of its heart failure drug Entresto.

Judge Dabney L. Friedrich of the US District Court for the District of Columbia in an Oct. 13 order denied Novartis’ motion for summary judgment, which requested the court declare the Food and Drug Administration’s approval of MSN Laboratories’ generic version of Entresto unlawful and vacate it as well.

In the sealed memorandum, the judge granted the FDA’s cross motion for summary judgment. The parties were ordered to propose any redactions to the ...

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