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. •This summary of novel drugs approved by the FDA in 2019 provides clinicians with pertinent prescribing information for each new drug. •Clinicians will find this information useful when discussing these new drugs with their patients who may request them as part of their care. •This information may be useful as clinicians work with hospitals and other healthcare organizations that are considering addition of these drugs to their prescribing formularies.