Novel drug approvals by US FDA for 2023

10 January 2024

The US Food and Drug Administration has published a list of the novel drug that it approved for marketing in 2023.

The total number of new drug applications (NDAs) authorized last year was 55. This compares with just 37 approvals in 2022, a particularly low number,and 50 approvals in 2021.

This listing does not contain vaccines, allergenic products, blood and blood products, plasma derivatives, cellular and gene therapy products, or other products that the Center for Biologics Evaluation and Research approved in 2023.

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