New Drugs Approved in 2020

Alex M Ebied; Hesham Elmariah; Rhonda M Cooper-DeHoff

doi:10.1016/j.amjmed.2021.03.034

New Drugs Approved in 2020

Am J Med. 2021 Sep;134(9):1096-1100. doi: 10.1016/j.amjmed.2021.03.034. Epub 2021 Apr 30.

Authors

Alex M Ebied¹, Hesham Elmariah², Rhonda M Cooper-DeHoff³

Affiliations

¹ Department of Clinical Sciences, High Point University Fred Wilson School of Pharmacy, NC.
² Ross University School of Medicine, Bridgetown, Barbados.
³ Department of Pharmacotherapy and Translational Research, University of Florida College of Pharmacy, Gainesville. Electronic address: dehoff@cop.ufl.edu.

PMID: 33939997
DOI: 10.1016/j.amjmed.2021.03.034

Abstract

In 2020, the US Food and Drug Administration approved 53 novel drugs. Thirty-six of the 53 (68%) drugs were reviewed and approved through an expedited review pathway, and 31 of the 53 (58%) were approved for treatment of a rare disease. This review includes a summary of the novel drugs approved by the US Food and Drug Administration in 2020.

Keywords: Accelerated approval; Fast track; Novel drugs; Priority review; US Food and Drug Administration.

Publication types

Review

MeSH terms

Drug Approval* / methods
Drug Approval* / organization & administration
Drug Therapy / trends
Humans
Pharmaceutical Preparations / classification
Rare Diseases / drug therapy
United States

Substances

Pharmaceutical Preparations