Posted by Michael Wonder on 02 Feb 2017
OptiNose announces FDA acceptance for filing of the new drug application for OPN-375
31 January 2017 - FDA sets user fee goal date in September 2017.
OptiNose today announced the U.S. FDA has accepted for review the company’s new drug application for the investigational new product OPN-375.
OptiNose is seeking marketing approval of OPN-375 in the U.S. for the treatment of nasal polyposis in adults. Under the Prescription Drug User Fee Act, a decision on the application is anticipated in September 2017.
