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In September 2017, we received FDA approval for XHANCE® (fluticasone propionate). Please see Instructions for Use, Important Safety Information, and full Prescribing Information at www.XHANCE.com. ONZETRA® Xsail® (sumatriptan nasal powder), licensed to Currax Pharmaceuticals LLC, has been approved for the delivery of low-dose sumatriptan using an Optinose Bi-Directional™ Exhalation Delivery System. See Instructions for Use, Important S…
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Compliance Program OptiNose US, Inc. and its parent, affiliate, and subsidiary companies (collectively, “Optinose”) are committed to conducting business in compliance with all applicable federal and state laws and regulations. To that end, Optinose has established and maintains an effective Compliance Program in accordance with the “Compliance Program Guidance for Pharmaceutical Manufacturers,” published by the Office of Inspector General, U.S….
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To report a side effect or product complaint, call 1-833-678-6673 or contact the FDA directly by calling 1-800-FDA-1088 or visiting www.fda.gov/medwatch. For all other inquiries, complete the form below to be contacted by Optinose. Inquiry Type* Select Option Business Development/Partnership Opportunities Commercial Inquiries Medical/Scientific Questions Investor Inquiries Clinical Services (CRO) Quest…
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777 Township Line Road, SUITE 300, Yardley, PA 19067 GPS note: The city, state may come up as “Morrisville, PA” From Points South (Philadelphia) Take I-95 North to I-295 East (Stay left on I-95 North and it will become I-295 East) Take exit 8 Newtown/Yardley (formerly exit 49). Turn left at the traffic light at the top of the ramp, onto Route 332 West. You will cross over I-95; make second left onto Stony Hill Road (this is a very short dista…
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Other Drug-Device Product Candidates Combining Drug with Exhalation Delivery Systems Although our current focus is to prioritize the successful commercialization of XHANCE for the ENT and allergy specialty segment, we may apply or out-license our Exhalation Delivery System (EDS) technology to other product candidates across a broad range of disease areas. For example, by placing drug high and deep in the nose, in regions where cranial nerves con…