FDA also approves packaging redesign for Mucinex and Mucinex-DM and final changes to labeling text and location on packaging. Granules Pharmaceuticals’ generic of Excedrin Migraine also among CDER’s decisions on OTC ANDAs and sNDAs during January-March.

Settlement in Southern District of Florida federal court includes a consolidated class action complaint against UK firm’s US businesses comprising cases in Florida, New York and California – filed in 2020 over statements the products were “clinically proven” to improve “brain performance” including focus, memory, learning, accuracy, concentration and reasoning.

President Biden’s picks to fill two commissioner posts may shift dynamics on pharmaceutical industry enforcement. Rohit Chopra’s nomination to Consumer Financial Protection Bureau removes strong critic of pharma mergers.

Following cyberattack, chief information officer Mukesh Rathi said Dr Reddy's was “anticipating all services to be up within 24 hours,” adding that “we do not foresee any major impact on our operations due to this incident.”