FDA approves over-the-counter Nasacort Allergy 24HR to treat hay fever and nasal allergies

[10-11-2013] The U.S. Food and Drug Administration today approved Nasacort Allergy 24HR (triamcinolone acetonide), a nasal spray for the nonprescription or over-the-counter (OTC) treatment of nasal allergy symptoms (nasal congestion, runny nose, sneezing, and itchy nose). Nasacort Allergy 24HR is labeled for use in children 2 years of age and older, adolescents, and adults.

Nasacort Allergy 24HR belongs to a class of drugs known as glucocorticoids. It is the first drug in this class to be made available OTC for treatment of the symptoms of nasal allergies.

Nasacort Allergy 24HR is a nasal spray and is indicated for use once daily. There are different dosing instructions for adults and children 12 years of age and older, children 6 to under 12 years of age, and children 2 to under 6 years of age. Nasacort Allergy 24HR should not be used in children under age 2. Additional information included in the labeling informs consumers that when using this product, the growth rate of some children might be slightly slower. The labeling also states that if a child needs to use the spray for longer than two months a year, the parent should talk to the child’s doctor.

Nasacort Allergy 24HR was initially approved as a prescription-only product (called Nasacort AQ) in the U.S. in 1996 for use in adults and adolescents 12 years of age or older. In 1997 it was approved for children 6 through 11 years of age and older, and in 2008 it was approved for children 2 through 5 years of age.

Nasacort is marketed by Sanofi-aventis U.S. Inc. based in Bridgewater, N.J.

Note: FDA’s approval of Nasacort is an activity that is funded under FDA’s user fee program in the Center for Drug Evaluation and Research (CDER). Some excepted FDA activities that do not rely on annual appropriations are continuing during the government shutdown.