New Drugs Approved in 2019.


Department of Pharmacotherapy and Translational Research, University of Florida College of Pharmacy, Gainesville, FL. Electronic address: [Email]


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.


FDA,accelerated approval,fast track,novel drugs,priority review,

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