FDA OKs OTC Triamcinolone (Nasacort) Nasal Spray

Megan Brooks

Disclosures

October 11, 2013

The US Food and Drug Administration (FDA) has approved triamcinolone acetonide (Nasacort Allergy 24HR, Sanofi) nasal spray for over-the-counter (OTC) treatment of nasal allergy symptoms (nasal congestion, runny nose, sneezing, and itchy nose), the agency announced today.

Nasacort Allergy 24HR is labeled for use in children aged 2 years or older, adolescents, and adults. Nasacort Allergy 24HR should not be used in children aged under 2 years.

Nasacort Allergy 24HR is the first glucocorticoid to be made available OTC for treatment of the symptoms of nasal allergies, the FDA said.

It is indicated for once-daily use. There are different dosing instructions for adults and children aged12 years or older, children aged 6 to under 12 years, and children aged 2 to under 6 years, the FDA said.

"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," the FDA said.

In July 2013, as reported by Medscape Medical News, a federal advisory panel voted 10 to 6, with 2 abstentions to allow Nasacort to be switched from prescription to OTC, but with the proviso that the product label must clearly reflect the risk for slowing of growth in children, among other concerns.

Nasacort is already approved for OTC use in 11 countries, with a variety of age restrictions.

The company said in a news release that it anticipates Nasacort will be available next spring.

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