FDA
27th June 2013

Meeting Announcement – NASACORT AQ Rx to OTC Switch

July 31, 2013 8:00 a.m. to 5:00 p.m.: Meeting of the Nonprescription Drugs Advisory Committee Announcement.

Meeting Announcement – NASACORT AQ Rx to OTC Switch

July 31, 2013 8:00 a.m. to 5:00 p.m.: Meeting of the Nonprescription Drugs Advisory Committee Announcement

 

Where:

DoubleTree by Hilton Hotel
Washington DC/Silver Spring
The Ballrooms
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.

ISS has over a decade of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComms per year than even the largest pharmaceutical companies. For more information on how ISS can help you prepare for your next meeting, contact info@innovativescience.net.

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