Novel drug approvals

In 2025, CDER approved 46 new drugs never before approved or marketed in the U.S., known as “novel” drugs.

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APA

U.S. Food and Drug Administration. (2025). Novel Drug Approvals for 2025. Retrieved September 17, 2026, from https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025. Via StatOrigin, https://statorigin.org/stat/stat_FYPH5BNZDF28G5Z8B3HWEGC64Z

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MLA

U.S. Food and Drug Administration. "Novel Drug Approvals for 2025." 2025, https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025. Accessed 17 Sept. 2026 via StatOrigin, https://statorigin.org/stat/stat_FYPH5BNZDF28G5Z8B3HWEGC64Z.

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Chicago

U.S. Food and Drug Administration. "Novel Drug Approvals for 2025." 2025. https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025. Accessed September 17, 2026. Cited from StatOrigin, https://statorigin.org/stat/stat_FYPH5BNZDF28G5Z8B3HWEGC64Z.

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BibTeX

@misc{fda2025novelegc64z, author = {{U.S. Food and Drug Administration}}, title = {Novel Drug Approvals for 2025}, year = {2025}, howpublished = {StatOrigin, https://statorigin.org}, url = {https://statorigin.org/stat/stat_FYPH5BNZDF28G5Z8B3HWEGC64Z}, note = {Original source: https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025. Accessed September 17, 2026.} }

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Record last modified 17 September 2026. Value type: actual. Update cadence: annual. This page is permanently addressable at statorigin.org/stat/stat_FYPH5BNZDF28G5Z8B3HWEGC64Z.