US OTC Switch Drought Ends: FDA Approves GSK Arthritis Gel, Alcon Allergy Eye Drops
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...
Supplement industry’s bullseye on “60 Minutes” after its June segment critical of probiotic health benefits generated the most reads for a US consumer health and overall for HBW Insight articles in 2020. Articles about COVID-19 enforcement actions weren’t as widely read as coverage of FDA’s reorganization in its OTC drug offices and its approvals of additional ingredients to be available OTC.
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.
Consultant Susan Levy points out Alcon’s Pataday eye drops and GSK's Voltaren Arthritis Relief as examples of effective switch advertising, marketing and management. Pfizer’s Advil line has been available far longer but also is an example of effective nonprescription brand management.