The AAPS Journal

, 21:14 | Cite as

Scientific Considerations for the Review and Approval of First Generic Mometasone Furoate Nasal Suspension Spray in the United States from the Bioequivalence Perspective

  • Qing Liu
  • Mohammad Absar
  • Bhawana Saluja
  • Changning Guo
  • Badrul Chowdhury
  • Robert Lionberger
  • Dale P. Conner
  • Bing V. LiEmail author
Regulatory Note


In 2016, the US Food and Drug Administration (FDA) approved the first Abbreviated New Drug Application for Mometasone Furoate Nasal Suspension Spray. To establish the bioequivalence of this generic nasal suspension spray with the reference listed drug product (RLD), Nasonex®, a “weight-of-evidence” approach was utilized by the applicant that included formulation and device similarities, equivalent in vitro performance, equivalent systemic exposure, and equivalent local delivery. In addition to these testing for comprehensive evaluation of the drug product, FDA also considered supportive data generated by a novel in vitro method, Morphologically-Directed Raman Spectroscopy (MDRS), to characterize the particle size distribution (PSD) of active pharmaceutical ingredient (API) in the drug product. In this case, MDRS data eliminated the need for a comparative clinical endpoint bioequivalence study. The approval of the first generic Mometasone Furoate Nasal Suspension Spray is precedent-setting and paves a new pathway to establish bioequivalence for generic nasal suspension sprays. This approval also exemplifies FDA’s commitment to advance regulatory science for evaluation of generic drug products.


bioequivalence weight-of-evidence nasal suspension spray particle size distribution 


Compliance with Ethical Standards


This article reflects the views of the author and should not be construed to represent the Food and Drug Administration’s view or policies.


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Copyright information

© American Association of Pharmaceutical Scientists 2019

Authors and Affiliations

  • Qing Liu
    • 1
  • Mohammad Absar
    • 1
    • 2
  • Bhawana Saluja
    • 1
    • 2
  • Changning Guo
    • 3
  • Badrul Chowdhury
    • 4
    • 5
  • Robert Lionberger
    • 1
  • Dale P. Conner
    • 1
  • Bing V. Li
    • 1
    Email author
  1. 1.Office of Generic Drugs, Center for Drug Evaluation and ResearchUS Food and Drug AdministrationSilver SpringUSA
  2. 2.Office of Translational Research, Center for Drug Evaluation and ResearchUS Food and Drug AdministrationSilver SpringUSA
  3. 3.Office of Pharmaceutical Quality, Center for Drug Evaluation and ResearchUS Food and Drug AdministrationSilver SpringUSA
  4. 4.Office of New Drugs, Center for Drug Evaluation and ResearchUS Food and Drug AdministrationSilver SpringUSA
  5. 5.Respiratory, Inflammation and Autoimmunity, MedimmuneAstraZeneca PharmaceuticalsGaithersburgUSA

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