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Novartis Takes Fight To The FDA After US Entresto Generic Approval

Originator Cites Labeling Carve-Outs And ‘Same Active Ingredient’ Requirements

 
• By Dean Rudge

Citizen petitions, Hatch-Waxman, and now a lawsuit against the FDA itself: Novartis continues to fight tooth and nail to protect its core $3bn Entresto brand in the US, following the latest agency approval of a generic version. Generics Bulletin dives into the originator’s complaint against the FDA.

Lawsuits magnifying glass
• Source: Shutterstock

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

Filed in the US District Court for the District of Columbia, Novartis’ complaint seeks temporary, preliminary, and permanent injunctive relief setting aside the approval handed out

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