New Drugs Approved in 2019

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.

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