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FDA Advisors Say Allergy Drug Is Safe for OTC Use
Nasacort AQ would be first OTC steroid nasal spray in US (July 29)
According to a report from Reuters, the FDA’s Nonprescription Drug Advisory Committee has ruled that triamcinolone acetonide nasal spray (Nasacort AQ, Sanofi Aventis) is safe enough for over-the-counter (OTC) use.
The committee announced its opinion ahead of an FDA meeting set for July 31, which will consider whether the product’s indication should be switched from a prescription to a nonprescription status for the treatment of the symptoms of hay fever or other upper respiratory allergies.
Nasacort AQ was first approved for the treatment of nasal symptoms of seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR) in patients 12 years of age and older in 1996. Use of the product in children aged 6 to less than 12 years and in children aged 2 to less than 6 years was approved in 2007 and 2008, respectively.
While intranasal corticosteroids have been available by prescription for the treatment of rhinitis for more than 30 years, no approved OTC intranasal corticosteroid products are currently available in the US.