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...
GSK will market Advil Dual Action with Acetaminophen noting potential risks for both of the product’s active ingredients with labeling highlights FDA requires. It can counter labeling about risks by noting studies show the combination has better efficacy than larger doses of each drug used separately.
OTC Decisions In February: 2 Switches, Label Changes For Excedrin, FeverAll, Naproxen From Biopharma
FDA approved two switches on one day in February, diclofenac gel and olopatadine ophthalmic drops, and stayed busy on OTCs through the month with label changes for Excedrin Migraine packaged with 2-count pouches and for Taro's FeverAll suppositories, and an NDA approval for Biopharma's naproxen.
OTC private label giant said gaining another grocery chain as an infant formula customer was a key sales driver in the 2019 Q4, with nutrition sales up 21% to account for 17% of Americas consumer health sales growth. The firm plans to re-enter the broader VMS space, but infant formula helped its global consumer health net sales reach $1.1bn in the October-December period.