New Drug Approvals in 2018 - Another Record Year!

Alex M Ebied; Juri Na; Rhonda M Cooper-DeHoff

doi:10.1016/j.amjmed.2019.02.024

New Drug Approvals in 2018 - Another Record Year!

Am J Med. 2019 Sep;132(9):1038-1043. doi: 10.1016/j.amjmed.2019.02.024. Epub 2019 Mar 7.

Authors

Alex M Ebied¹, Juri Na¹, Rhonda M Cooper-DeHoff²

Affiliations

¹ Department of Pharmacotherapy and Translational Research, University of Florida College of Pharmacy, Gainesville, Fla.
² Department of Pharmacotherapy and Translational Research, University of Florida College of Pharmacy, Gainesville, Fla. Electronic address: dehoff@cop.ufl.edu.

PMID: 30853471
DOI: 10.1016/j.amjmed.2019.02.024

Abstract

In 2018, the US Food and Drug Administration approved 59 novel drugs. This all-time record was due primarily to the expedited review pathways; 43 of the 59 (73%) novel drug approvals were designated in an expedited review pathway, and 34 of the 59 (58%) were approved for treatment of rare diseases. A review of these novel drugs is summarized.

Keywords: Accelerated approval; FDA; Fast track; Novel drugs; Priority review.

Publication types

Review

MeSH terms

Drug Approval / statistics & numerical data*
Humans
United States
United States Food and Drug Administration