Novartis Cites ‘Same Labelling’ Rule In FDA Entresto Petition
‘At Least Entresto 18 ANDAs Have Been Submitted To FDA,’ Novartis Reveals
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.
You may also be interested in...
Having strongly made the case for Jardiance as a treatment for chronic heart failure, Boehringer Ingelheim and Eli Lilly believe the SGLT2 inhibitor could have a lot of potential in acute heart failure as well after promising data from the EMPULSE study.
Novartis has secured an injunction order against alleged infringers of heart failure therapy Entresto in India. Court also makes key observations around the “scientific opinion”, which had gone in favor of challenger Natco.
Keeping Track: Novartis Entresto Wins Expanded Heart Failure Claim; Padcev, Vicineum Seek Bladder Cancer Approvals
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker