FDA advisory committee recommends approval of Nasacort AQ nasal spray OTC

According to Sanofi, the FDA’s Nonprescription Drugs Advisory Committee (NDAC) voted 10 to 6, with two members abstaining, to recommend making Nasacort AQ triamcinolone acetonide nasal spray available without a prescription in the US. If the FDA approves the application, Sanofi’s consumer healthcare division, Chattem, Inc. will market Nasacort AQ.

Sanofi US Chief Medical Officer Charles Hugh-Jones commented, “Today’s positive NDAC vote was an important step forward in providing broader access to Nasacort AQ for nasal allergy sufferers. We appreciate the feedback from the committee and look forward to working with FDA in completing its review.”

Patient advocacy group Allergy & Asthma Network Mothers of Asthmatics (AANMA) opposes approval of Nasacort AQ as an OTC product.

Read the Sanofi press release.