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# OptiNose Wants Xhance Bioequivalence Restrictions
- URL: https://www.fdaweb.com/optinose-wants-xhance-bioequivalence-restrictions/
- Published: 2021-06-08T12:00:00.000Z
- Updated: 2026-09-14T17:02:14.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149486

OptiNose is petitioning FDA to take specific actions regarding any ANDA or section 505(b)(2) application that references or relies upon the company’s Xhance (fluticasone propionate) nasal spray. A 5/31 [petition](https://downloads.regulations.gov/FDA-2021-P-0530-0001/attachment%5F1.pdf?ref=fdaweb.com) asks that the agency: 

- not approve an ANDA referencing Xhance unless the applicant demonstrates bioequivalence and therapeutic equivalence through a non-inferiority clinical endpoint study in addition to *in vitro* studies, pharmacokinetic study data, quantitative and quantitativeness sameness of excipients, and an adequate showing of device equivalence;
- issue a draft product-specific guidance with recommendations that are consistent with the company requests; and
- not assign an “A” rating for a section 505(b)(2) product unless the applicant demonstrates bioequivalence and therapeutic equivalence through a non-inferiority clinical endpoint study.