Analysis of Fixed-Dose Combination Products Approved by the US Food and Drug Administration, 2010-2015: Implications for Designing a Regulatory Shortcut to New Drug Application

Kyu Chan Kwon, Chul Ung Lee

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

Background: Fixed-dose combination (FDC) drugs have been an attractive product in pharmaceutical markets because of their unique advantages, but general guidance directing the clinical development of FDC drugs is not yet available in the US. Method: All drug approval reports of FDC products approved by the US FDA from January 2010 to December 2015 were intensively analyzed to investigate the regulatory requirements of the US FDA. Result: Through analyzing 63 approved FDCs out of 655 New Drug Application (NDA) approvals, it was found that completion of the full phases of clinical trials was not always required for approval by the FDA, which indicates that some phases of clinical studies can be possibly exempted, if justified. Conclusion: The results imply that pharmaceutical companies can accelerate FDC development and enter the market earlier if scientific regulatory rationales are established.

Original languageEnglish
Pages (from-to)111-117
Number of pages7
JournalTherapeutic Innovation and Regulatory Science
Volume51
Issue number1
DOIs
Publication statusPublished - 2017 Jan 1

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Drug Approval
Drug Combinations
United States Food and Drug Administration
Pharmaceutical Preparations
Clinical Trials
Clinical Studies

Keywords

  • approval
  • clinical
  • FDA
  • fixed-dose combination
  • NDA
  • regulatory

ASJC Scopus subject areas

  • Pharmacology, Toxicology and Pharmaceutics (miscellaneous)
  • Public Health, Environmental and Occupational Health
  • Pharmacology (medical)

Cite this

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abstract = "Background: Fixed-dose combination (FDC) drugs have been an attractive product in pharmaceutical markets because of their unique advantages, but general guidance directing the clinical development of FDC drugs is not yet available in the US. Method: All drug approval reports of FDC products approved by the US FDA from January 2010 to December 2015 were intensively analyzed to investigate the regulatory requirements of the US FDA. Result: Through analyzing 63 approved FDCs out of 655 New Drug Application (NDA) approvals, it was found that completion of the full phases of clinical trials was not always required for approval by the FDA, which indicates that some phases of clinical studies can be possibly exempted, if justified. Conclusion: The results imply that pharmaceutical companies can accelerate FDC development and enter the market earlier if scientific regulatory rationales are established.",
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