Novartis Takes Fight To The FDA After US Entresto Generic Approval
Originator Cites Labeling Carve-Outs And ‘Same Active Ingredient’ Requirements
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.
