Posted by Michael Wonder on 22 Feb 2023
Optinose submits supplemental new drug application for Xhance label expansion
21 February 2023 - Optinose today announced the submission of its supplemental new drug application to the US FDA to request approval of Xhance as a treatment for chronic rhinosinusitis.
The supplemental new drug application 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 16 February 2023.
