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Novartis Cites ‘Same Labelling’ Rule In FDA Entresto Petition

‘At Least Entresto 18 ANDAs Have Been Submitted To FDA,’ Novartis Reveals

Executive Summary

Ahead of a proposed patent infringement trial set for September 2022, Novartis is urging the FDA not to approve any generic versions of its blockbuster heart failure therapy Entresto before February 2024 at the earliest, in part because of the agency’s own ‘same labelling’ regulations for ANDA products.

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