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; Chulung Lee

doi:10.1177/2168479016663263

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

Ther Innov Regul Sci. 2017 Jan;51(1):111-117. doi: 10.1177/2168479016663263. Epub 2016 Sep 27.

Authors

Kyu Chan Kwon^{1

2}, Chulung Lee³

Affiliations

¹ 1 Graduate School of Management of Technology, Korea University, Seoul, Korea.
² 2 Global Regulatory Affairs, Hanmi Pharmaceuticals, Seoul, Korea.
³ 3 School of Industrial Management of Engineering, Korea University, Seoul, Korea.

PMID: 30235996
DOI: 10.1177/2168479016663263

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.

Keywords: FDA; NDA; approval; clinical; fixed-dose combination; regulatory.