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

Author:

Liu Qing,Absar Mohammad,Saluja Bhawana,Guo Changning,Chowdhury Badrul,Lionberger Robert,Conner Dale P.,Li Bing V.

Publisher

Springer Science and Business Media LLC

Subject

Pharmaceutical Science

Reference15 articles.

1. https://www.fiercepharma.com/special-report/nasonex-merck

2. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=320.23 . Last assessed 07/08/2018.

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 FDA Draft Guidance for Industry.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. 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.

5. https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM461141.pdf (Recommended September 2015).

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