OTC Allergy Drug Use Increases: A Symptom With Multiple Causes
This article was originally published in The Pink Sheet
CHPA says growing use of allergy OTCs from 2009 through 2015 in the US is a sign of more consumers prioritizing self-care over using health care services, but allergy specialists say their patients often have to start with an OTC even when they have a prescription.
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CDER’s approval of McNeil’s supplemental NDA for the budesonide spray came without an advisory committee opinion, a step the agency required for the first switch in the category, Glaxo’s Flonase Allergy Relief. OTC Rhinocort is indicated for temporary relief of symptoms of hay fever or other upper respiratory allergies in adults and children ages 6 and up, with separate directions for use by children ages 6 to 12.
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.”
The firm’s Chattem division will bring the 24-hour nasal allergy spray to market in the spring of 2014.