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Am J Med. 2020 Jun;133(6):675-678. doi: 10.1016/j.amjmed.2020.01.030. Epub 2020 Mar 05.

New Drugs Approved in 2019.

The American journal of medicine

Alex M Ebied, Khushboo H Patel, Rhonda M Cooper-DeHoff

Affiliations

  1. Department of Clinical Sciences, High Point University Fred Wilson School of Pharmacy, High Point, NC.
  2. Department of Pharmacy, Vidant Medical Center, Greenville, NC.
  3. Department of Pharmacotherapy and Translational Research, University of Florida College of Pharmacy, Gainesville, Fla. Electronic address: [email protected].

PMID: 32145207 DOI: 10.1016/j.amjmed.2020.01.030

Abstract

In 2019, the US Food and Drug Administration (FDA) approved 48 novel drugs. Thirty of the 48 (62.5%) novel drug approvals were reviewed and approved through an expedited review pathway while 20 of the 48 (41.7%) were approved for treatment of a rare disease. This review includes a summary of the novel drugs approved by the FDA in 2019.

Copyright © 2020 Elsevier Inc. All rights reserved.

Keywords: Accelerated approval; Fast track; Food and Drug Administration (FDA); Novel drugs; Priority review

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