July 31, 2013 8:00 a.m. to 5:00 p.m.: Meeting of the Nonprescription Drugs Advisory Committee Announcement.
July 31, 2013 8:00 a.m. to 5:00 p.m.: Meeting of the Nonprescription Drugs Advisory Committee Announcement
DoubleTree by Hilton Hotel
Washington DC/Silver Spring
8727 Colesville Road
Silver Spring, Maryland
On July 31, 2013, the committee will discuss data submitted by Sanofi-aventis U.S., LLC to support a supplemental new drug application (sNDA) 20468/S-035, for the switch from prescription to over-the-counter (OTC) of their intranasal corticosteroid Nasacort AQ (triamcinolone acetonide). The proposed OTC use is “temporarily relieves these symptoms of hay fever or other upper respiratory allergies: nasal congestion, runny nose, sneezing, itchy nose.” The data to be discussed will include studies addressing the potential adverse effects, as well as a summary of the postmarketing experience with the triamcinolone acetonide nasal spray addressing the potential for both systemic and local effects. The committee will be asked to consider whether the data support the appropriate and safe use of triamcinolone acetonide nasal spray by OTC consumers.
Please click HERE for the current roster of the Nonprescription Drugs Advisory Committee.
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