OTC Decisions August-October: More Providers Enter Diclofenac, Lansoprazole, Loratadine Markets
Executive Summary
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.
You may also be interested in...
Science-Backed Products, Better User Experience Sell Self-Care – Bayer Consumer Research Chief
Self-care within next decade should help consumers prevent common ailments, says Bayer consumer health research executive Dave Evendon-Challis. Bayer aims to steer consumers into effective self-care using credible science behind its products and improving the user experience.
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.
Salonpas Spreads Into OTC Diclofenac Arthritis Gel
Hisamitsu America launches Salonpas Arthritis Pain Relief Gel with same active ingredient, diclofenac sodium 1% gel, that became available OTC for the first time in the US in 2020 with GSK’s Voltaren Arthritis Pain formulation.