2019 in review: FDA approvals of new medicines

Michael S. Kinch, Zachary Kraft, Tyler Schwartz

Research output: Contribution to journalShort surveypeer-review

Abstract

The US Food and Drug Administration (FDA) green-lighted the marketing of 53 therapeutic agents in 2019. This rate of approvals was consistent with the 5-year running average. Nonetheless, a few changes are worth noting. The rate of medicines first approved using an orphan drug designation declined from 56% in 2018 to 41% in 2019, which mirrored a comparable decline in the use of priority review. A second notable feature was an uptick in industry consolidation. Twenty-five companies were lost, primarily because of mergers, leaving only 146 extant companies that have contributed to the research or development of an innovative FDA-approved medicine.

Original languageEnglish
Pages (from-to)1923-1929
Number of pages7
JournalDrug Discovery Today
Volume25
Issue number11
DOIs
StatePublished - Nov 2020

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