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
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Novartis has asked a federal court to set aside the FDA approval of an Entresto generic.
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The company cited labeling and other issues in the suit filed in DC District Court
Filed in the US District Court for the District of Columbia, Novartis’ complaint seeks temporary, preliminary, and permanent injunctive relief setting aside the approval of an abbreviated new drug