October 23, 2013
First OTC Glucocorticoid Spray Approved for
Nasal Allergy Treatment
Chattanooga, TN—Look for the first OTC glucocorticoid nasal spray approved for treatment of nasal allergies to be on drugstore shelves by the spring.
The FDA recently approved Nasacort Allergy 24HR (triamcinolone acetonide) for OTC treatment of nasal congestion, runny nose, sneezing, and itchy nose. It is labeled for use in children 2-years-old and older, as well as adolescents and adults.
The product will be marketed by Sanofi’s consumer healthcare division, Chattanooga, TN-based Chattem, Inc., which estimates availability by spring 2014.
Initially FDA-approved in 1996 as a prescription-only product called Nasacort AQ for use in adults and adolescents 12 years of age or older, approval for children 6 through 11 years of age and older was added in 1997 and for children 2 through 5-years-old in 1998.
The OTC formulation, Nasacort Allergy 24HR, is indicated for use once daily, with different dosing instructions for adults and children in three categories—12 years of age and older, children 6 to under 12 years of age, and children 2 to under 6 years of age.
The FDA cautions that the growth rate of some children might be slightly slower when they use the product. The label also states that a physician should be consulted if a child needs to use the spray for longer than 2 months a year.
The FDA approval of Nasacort Allergy 24HR as an OTC treatment was based on data submitted from 13 placebo-controlled efficacy studies and safety information from 43 clinical studies, as well as information from 16 years of postmarketing surveillance data for Nasacort AQ, according to Sanofi U.S.
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