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Novartis Takes Fight To The FDA After US Entresto Generic Approval

 
• By Dean Rudge

Novartis continues to fight tooth and nail to protect its $3bn Entresto brand in the US following the latest FDA approval of a generic version.

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Novartis wants a court to set aside the FDA's approval of an Entresto generic. • Source: Shutterstock

Novartis AG has swiftly filed suit against the US Food and Drug Administration after the agency’s denial of a second citizen petition opened the door for what the Swiss originator company claims is an “unlawful” approval of a generic version of its Entresto (sacubitril/valsartan), the $3bn heart failure powerhouse.

Key Takeaways

  • Novartis has asked a federal court to set aside the FDA approval of an Entresto generic.

Filed in the US District Court for the District of Columbia, Novartis’ complaint seeks temporary, preliminary, and permanent injunctive relief...

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