US OTC Switch Drought Ends: FDA Approves GSK Arthritis Gel, Alcon Allergy Eye Drops
Executive Summary
FDA approved sNDAs from GlaxoSmithKline for diclofenac-containing Voltaren Arthritis Pain for the temporary relief of arthritis pain and from Alcon for Pataday olopatadine drops at 0.2% concentration for once-daily use temporary relief of itchy eyes due to pollen, ragweed, grass, animal hair or dander and 0.1% for twice-daily use for the same indications plus redness relief.
You may also be interested in...
Bayer Spreads Aleve Brand Into Topical Pain Relief
Three-product AleveX line contains menthol and camphor for minor muscle and joints aches and pains with a cooling sensation. Bayer Healthcare promotes launch with an ad campaign featuring basketball legend and TV personality Charles Barkley.
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.
In GSK Challenge Of Salonpas Claims, NAD Embarks On Review Of Unchartered Argument
Hisamitsu America’s severity of pain claims for Salonpas challenged by GSK are more nuanced than what label indications support, but touting its regulatory approval doesn’t convey a message that other products aren’t subject to as rigorous pre-market evaluations.