Optinose (NASDAQ:OPTN), a pharmaceutical company focused on patients treated by ear, nose and throat (ENT) and allergy specialists, today announced the submission of its supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) to request approval of XHANCE as a treatment for chronic rhinosinusitis. XHANCE® (fluticasone propionate) nasal spray is a drug device combination product combining an anti-inflammatory drug with the innovative Exhalation Delivery System™ (EDS™) that is designed to uniquely deliver drug high and deep into nasal passages. The sNDA submission is based on data from the two Phase 3 clinical trials from the ReOpen Program in patients suffering from chronic sinusitis and was submitted to the FDA on February 16, 2023.
https://finance.yahoo.com/news/optinose-submits-supplemental-drug-application-120000097.html
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.