Novel Drug Approvals for 2023

"Novel" drugs are new drugs never before approved or marketed in the U.S. See Drugs@FDA for information about all of CDER’s approved drugs and biological products.

FDA Novel Drug Therapy Approvals for 2023

In 2023, CDER approved 55 new drugs never before approved or marketed in the U.S., known as “novel” drugs. We also made other important approval decisions, such as expanding the use or patient population of previously approved drugs.
CDER’s novel drug approvals for 2023 are listed below. For more information, download the report Advancing Health Through Innovation: New Drug Therapy Approvals for 2023.

To treat moderate to severe hot flashes caused by menopause
Press Release
Drug Trials Snapshot

*The listed “FDA-approved use” on this website is for presentation purposes only. To see the FDA-approved conditions of use [e.g., indication(s), population(s), dosing regimen(s)] for each of these products, see the most recent A-approved Prescribing Information (click on the Drug Name).