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New Drugs Approved in 2022

      Abstract

      In 2022, the US Food and Drug Administration (FDA) approved 37 novel drugs. Twenty four of the 37 (65%) novel drug approvals were reviewed and approved through an expedited review pathway and 20 of the 37 (54%) were approved for treatment of a rare disease. This review includes a summary of the novel drugs approved by the FDA in 2022.

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      References

      1. US Food and Drug Administration (FDA). Novel drug approvals for 2022. Available at: https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2022. Accessed January 16, 2023.

      2. US Food and Drug Administration (FDA). New Drug Therapy Approvals 2022. Available at: https://www.fda.gov/media/164429/download. Accessed January 16, 2023.

      3. US Food and Drug Administration (FDA). FDA Drug Competition Action Plan. Available at: https://www.fda.gov/drugs/guidance-compliance-regulatory-information/fda-drug-competition-action-plan. Accessed January 16, 2023.

      4. US Food and Drug Administration (FDA). Generic Competition and Drug Prices: New Evidence Linking Greater Generic Competition and Lower Generic Drug Prices. Available at: https://www.fda.gov/media/133509/download. Accessed January 16, 2023.

      5. US Food and Drug Administration (FDA). Estimating Cost Savings from New Generic Drug Approvals in 2018, 2019, and 2020. Available at: https://www.fda.gov/media/161540/download. Accessed January 16, 2023.