Drugs

OptiNose Wants Xhance Bioequivalence Restrictions

David McFarland

— 1 min read
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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 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.

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