OptiNose Announces FDA Acceptance for Filing of the New Drug Application for OPN-375

FDA sets user fee goal date in September, 2017

YARDLEY, PA, January 31, 2017 – OptiNose™ today announced the U.S. Food and Drug Administration (FDA) has accepted for review the company’s New Drug Application (NDA) 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 (PDUFA), a decision on the application is anticipated in September, 2017.

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