Regulatory Focus™ > News Articles > Advisory Committee to Consider OTC Switch for Sanofi's Nasacort AQ

Advisory Committee to Consider OTC Switch for Sanofi's Nasacort AQ

Posted 24 June 2013 | By Alexander GaffneyRF News Editor

Since 2008, the US Food and Drug Administration (FDA) has only approved six prescription drug products for sale on an over-the-counter (OTC) basis without a prescription - a process known as an OTC "switch." Soon, a seventh drug may be joining their ranks.

In an announcement in the Federal Register on 24 June 2013, FDA said it would soon hold a meeting of its Nonprescription Drugs Advisory Committee (NDAC) to discuss a supplemental new drug application (sNDA) for Nasacort AQ (triamcinolone acetonide nasal spray) filed by French pharmaceutical manufacturer Sanofi-Aventis.

If approved, Nasacort AQ would be the third allergy product switched to OTC status since 1 January 2007. In 2007, FDA approved four variants of the antihistamine Zyrtec, and in 2011 approved three variants of the antihistamine Allegra.

As with the other allergy medications, Sanofi's Nasacort AQ would, if approved, be indicated for the temporary relief of symptoms associated with hay fever or other respiratory allergies, including nasal congestion, runny nose, sneezing and itchy nose. In addition, the drug is being supported with data regarding its use in both adults and children.

NDAC will be charged with issuing a recommendation to FDA on whether Nasacort AQ is safe for use in a broad range of unsupervised consumers who must self-select for treatment. FDA noted the data to be discussed will include adverse event data and postmarket experience data regarding systemic and local effects.

FDA's switch of Nasacort AQ would also mark its second switch since announcing a new "partial switch" paradigm in 2012. In January 2013 the agency granted partial OTC status to Oxytrol, a bladder control drug that was given OTC status for women. In men, regulators said they feared use of the drug could potentially mask prostate cancer, and kept the drug under prescription-only status.

The meeting will be held on 31 July 2013 in Silver Spring, MD.


Federal Register Notice


Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe