31.07.2013 23:56:37
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Sanofi's Nasacort AQ Nasal Spray Gets FDA Panel Backing
(RTTNews) - Sanofi (SNY) Wednesday said that the U.S. Food and Drug Administration's Nonprescription Drugs Advisory Committee has voted 10 to 6, with 2 abstentions, recommending approval of Nasacort AQ Nasal Spray (triamcinolone acetonide) for over-the-counter use in the U.S.
"Today's positive NDAC vote was an important step forward in providing broader access to Nasacort AQ for nasal allergy sufferers," said Charles Hugh-Jones, MD, MRCP, Chief Medical Officer, Sanofi US. "We appreciate the feedback from the Committee and look forward to working with FDA in completing its review."
If approved by the FDA, Nasacort AQ would be first-in-class as an OTC medicine and marketed by Sanofi's consumer healthcare division, Chattem, Inc. The proposed OTC indication is temporary relief of nasal symptoms of hay fever or other upper respiratory allergies in adults and children 2 years of age and older.
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