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Xhance FDA Approval History

Last updated by Judith Stewart, BPharm on March 17, 2024.

FDA Approved: Yes (First approved September 18, 2017)
Brand name: Xhance
Generic name: fluticasone propionate
Dosage form: Nasal Spray
Previous Name: OPN-375
Company: Optinose US, Inc.
Treatment for: Nasal Polyps, Chronic Rhinosinusitis With Nasal Polyps, Rhinitis

Xhance (fluticasone propionate) is a topical nasal corticosteroid indicated for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) and chronic rhinosinusitis without nasal polyps (CRSsNP) in adults.

Development timeline for Xhance

DateArticle
Mar 15, 2024Approval Xhance Approved by FDA as First and Only Medication Indicated for Treatment of Adults with Chronic Rhinosinusitis without Nasal Polyps
Sep 19, 2017Approval Optinose Announces FDA Approval of Xhance (fluticasone propionate) Nasal Spray for the Treatment of Nasal Polyps
Jan 31, 2017OptiNose Announces FDA Acceptance for Filing of the New Drug Application for OPN-375

Further information

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