{"id": 1084497, "name": "New drugs approved by the FDA", "unit": "approvals", "createdAt": "2025-07-29T11:32:58.000Z", "updatedAt": "2025-07-31T13:08:51.000Z", "coverage": "", "timespan": "1924-2025", "datasetId": 7171, "shortUnit": "", "columnOrder": 0, "shortName": "total_approvals", "catalogPath": "grapher/health/2025-07-16/drug_approvals/total_drug_approvals#total_approvals", "descriptionShort": "The annual number of new drugs approved by the US Food and Drug Administration (FDA). This is broken down into [new chemical drugs](#dod:new-chemical-entity), new vaccines, and other new biologics such as antibodies and gene therapies. The data does not include [generics](#dod:generic-drug), reformulations, or [biosimilars](#dod:biosimilar).", "descriptionProcessing": "- Biologicals approved by the CBER have been extracted from the FDA's \"Purple Book\", which lists all licensed biological products.\n- CDER approvals (which include some biologics and all chemical drugs) come directly from the \"Compilation of CDER NME and New Biologic Approvals\" database, which is published by CDER.\n- This dataset only contains new drugs ([new chemical entities](#dod:new-chemical-entity) and biologics). We removed [biosimilars](#dod:biosimilar) and [generics](#dod:generic-drug) from the dataset, by excluding the \"biosimilar\" or \"interchangeable\" license types as well as products with a reference product listed.", "type": "int", "grapherConfigIdETL": "019855f5-09b1-7807-be4b-257ae2bc70e5", "dataChecksum": "1237977210838809647", "metadataChecksum": "2481989436450217502", "datasetName": "CDER New Molecular Entity (NME) Drug and New Biologic Approvals", "updatePeriodDays": 365, "datasetVersion": "2025-07-16", "nonRedistributable": false, "display": {"unit": "approvals", "numDecimalPlaces": 0}, "schemaVersion": 2, "processingLevel": "major", "presentation": {"topicTagsLinks": ["Medicine & Biotechnology"]}, "descriptionKey": ["This data includes both [new drug applications](#dod:new-drug-application) (NDAs) and [biologics license applications](#dod:biologics-license-application) (BLAs) approved by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) of the FDA."], "dimensions": {"years": {"values": [{"id": 1924}, {"id": 1930}, {"id": 1936}, {"id": 1942}, {"id": 1944}, {"id": 1950}, {"id": 1954}, {"id": 1957}, {"id": 1958}, {"id": 1963}, {"id": 1967}, {"id": 1969}, {"id": 1970}, {"id": 1971}, {"id": 1974}, {"id": 1976}, {"id": 1977}, {"id": 1978}, {"id": 1979}, {"id": 1981}, {"id": 1983}, {"id": 1985}, {"id": 1986}, {"id": 1987}, {"id": 1988}, {"id": 1989}, {"id": 1990}, {"id": 1991}, {"id": 1992}, {"id": 1993}, {"id": 1994}, {"id": 1995}, {"id": 1996}, {"id": 1997}, {"id": 1998}, {"id": 1999}, {"id": 2000}, {"id": 2001}, {"id": 2002}, {"id": 2003}, {"id": 2004}, {"id": 2005}, {"id": 2006}, {"id": 2007}, {"id": 2008}, {"id": 2009}, {"id": 2010}, {"id": 2011}, {"id": 2012}, {"id": 2013}, {"id": 2014}, {"id": 2015}, {"id": 2016}, {"id": 2017}, {"id": 2018}, {"id": 2019}, {"id": 2020}, {"id": 2021}, {"id": 2022}, {"id": 2023}, {"id": 2024}, {"id": 2025}]}, "entities": {"values": [{"id": 371802, "name": "All new drug approvals", "code": null}, {"id": 371804, "name": "Other new biologics", "code": null}, {"id": 371803, "name": "New vaccines", "code": null}, {"id": 371805, "name": "New chemical drugs", "code": null}]}}, "origins": [{"id": 6886, "title": "CDER New Molecular Entity (NME) Drug and New Biologic Approvals", "description": "This dataset provides a listing of all new drugs approved from 1985 \u2013 2024 and regulated by the Center for Drug Evaluation and Research (CDER). The listed drugs include both small molecule drugs approved under a New Drug Application (NDA) and new biological products approved under a Biologics License Application (BLA). The product information, indications, and regulatory characteristics described in the compilation reflect the state of each application at the time of original marketing approval.\n\nThis dataset is a subset of all drugs approved by the FDA, as it does not include any biologics approved by the Center for Biologics Evaluation and Research (CBER) such as vaccines, allergenic products, or blood and blood components. It also does not include generic drugs or reformulations of existing drugs.", "producer": "US Food and Drug Administration", "citationFull": "Compilation of CDER New Molecular Entity (NME) Drug and New Biologic Approvals, United States Food and Drug Administration, https://www.fda.gov/drugs/drug-approvals-and-databases/compilation-cder-new-molecular-entity-nme-drug-and-new-biologic-approvals, (2025)", "attributionShort": "FDA", "urlMain": "https://www.fda.gov/drugs/drug-approvals-and-databases/compilation-cder-new-molecular-entity-nme-drug-and-new-biologic-approvals", "urlDownload": "https://www.fda.gov/media/177921/download?attachment", "dateAccessed": "2025-07-16", "datePublished": "2025", "license": {"url": "https://open.fda.gov/license/", "name": "CC0"}}]}