The US FDA Nonprescription Drugs Advisory Committee (NDAC) has recommended approval of Sanofi's Nasacort AQ nasal spray (triamcinolone acetonide) for over-the-counter use in the country.
Nasacort AQ Nasal Spray is indicated to treat the nasal symptoms of seasonal and perennial allergic rhinitis, including hay fever and other upper respiratory allergies in adults and children aged two years and more.
Sanofi US chief medical officer Charles Hugh-Jones said, "Today's positive NDAC vote was an important step forward in providing broader access to Nasacort AQ for nasal allergy sufferers."
Data from 13 placebo-controlled efficacy studies, and safety information from 43 clinical studies, as well as information from 16 years of post-marketing surveillance also support the approval.
Following the FDA approval, Nasacort AQ is expected to become an OTC medicine marketed by Chattem, Sanofi's consumer healthcare division.
Sanofi North America pharmaceuticals president Anne Whitaker said, "The OTC availability of Nasacort would continue to build on Chattem's highly successful OTC launch of Allegra and further expand our consumer healthcare offering."
