US Doctors Could Diagnose Mucinex Free Samples Following FDA Approval Of Labeling, Packages
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.
You may also be interested in...
CDER’s August-September OTC application approvals are highlighted by Arbor Pharmaceuticals’ ivermectin 0.5% lice treatment. Orange Book changes also include four firms’ approvals for labeling to market generic equivalents of Voltaren Arthritis Relief launched as an OTC switch since earlier in 2020.
OTC Decisions In May: Esomeprazole For Sun Pharma, Guaifenesin For Granules India, More NRTs For PLD During Slow Month For Approvals
CDER representative says staff’s time available for drug applications currently is affected by the FDA having employees work remotely in response to the novel coronavirus pandemic.
Changes for supporting OTC labeling for drugs currently available Rx-only and indicated for chronic, more complicated conditions, aren’t minor and won’t happen within limits of one-dimensional text media printed on OTC drug containers, packages and inserts.