“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.
In 2024, CDER approved 50 new drugs never before approved or marketed in the U.S., known as “novel” drugs. We also made other important approval decisions, such as approving previously approved drugs for new uses and broader patient populations. CDER’s novel drug approvals for 2024 are listed below. For more information, download the report.