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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
  • 92 Downloads

Abstract

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.

KEY WORDS

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

Notes

Compliance with Ethical Standards

Disclaimer

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

References

  1. 1.
  2. 2.
  3. 3.
    FDA. US. FDA Draft Guidance for Industry. Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action. 2003. https://www.fda.gov/downloads/Drugs/.../Guidances/ucm070111.pdf.
  4. 4.
    Li BV, et al. Bioequivalence for locally acting nasal spray and nasal aerosol products: standard development and generic approval. AAPS J. 2013;15(3):875–83.CrossRefGoogle Scholar
  5. 5.
  6. 6.
  7. 7.
  8. 8.
    Suman JD, Laube BL, Lin TC, Brouet G, Dalby R. Relevance of in vitro tests of nasal solutions to predict in vivo deposition. Pharm Res. 2002;19:1–6.CrossRefGoogle Scholar
  9. 9.
    Suman JD, Laube BL, Dalby R. Validity of in vitro tests on aqueous spray pumps as surrogates for nasal deposition, absorption, and biologic response. J Aerosol Med. 2006;19(4):510–21.CrossRefGoogle Scholar
  10. 10.
    Daley-Yates P, Kunka RL, Yin Y, Andrews SM, Callejas S, Ng C. Bioavailability of fluticasone propionate and mometasone furoate aqueous nasal sprays. Eur J Clin Pharmacol. 2004;60(4):265–8.CrossRefGoogle Scholar
  11. 11.
    Advisory Committee for Pharmaceutical Science, 07/17/2001.Google Scholar
  12. 12.
    Shur J, Farias G, Huck-Jones D, O'Grady C, Saluja B, Price R. Characterizing nasal suspensions for regulatory and scientific purposes. Respiratory Drug Delivery 2016. Google Scholar
  13. 13.
    Budesonide Inhalation Suspension Drug Label Information. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c52c5382-1400-44b9-95be-a30e1cf706da. (Updated December 11, 2018).
  14. 14.
  15. 15.

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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