Children's Flonase Is Latest Play For Nasal Allergy Spray Market Share
This article was originally published in The Tan Sheet & The Rose Sheet
Children's Flonase, like Children's Nasacort, is the same formulation and is indicated for the same overall age groups as the original product, but its labeling includes additional detail for use by children.
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Sanofi introduces Children’s Nasacort Allergy 24HR in the same formulation and dosage as the original OTC switch, but with “children’s” added to the package after approval by FDA. The firm promotes the product as the “first and only” 24-hour multi-symptom nasal allergy spray available OTC for children ages 2 and up.
Chattem appeals a National Advertising Division decision from a review of advertising comparing its Nasacort nasal allergy spray to GSK’s Flonase. The Sanofi business maintains NAD relied on a “cookbook” approach to determine whether claims for the product are substantiated.
FDA grants Glaxo market exclusivity for OTC as the first OTC fluticasone product, but with a label carve-out that limits exclusivity to the indication of “OTC use for temporary relief of ocular symptoms due to hay fever or other upper respiratory allergies.”