{"id": 1084496, "name": "New drugs approved in the United States, by designations", "unit": "approvals", "createdAt": "2025-07-29T11:32:58.000Z", "updatedAt": "2025-07-29T11:32:58.000Z", "coverage": "", "timespan": "1985-2024", "datasetId": 7171, "shortUnit": "", "columnOrder": 0, "shortName": "approvals", "catalogPath": "grapher/health/2025-07-16/drug_approvals/drug_approvals_designations#approvals", "descriptionShort": "The annual number of new drugs approved by the Center for Drug Evaluation and Research (CDER), that fall under each designation, including [Orphan Drugs](#dod:orphan-drug), [Fast Track](#dod:fda-fast-track), [Accelerated Approval](#dod:fda-accelerated-approval), [Breakthrough Therapy](#dod:breakthrough-therapy), and [Qualified Infectious Disease Product](#dod:qualified-infectious-disease-product).", "type": "int", "grapherConfigIdETL": "019855f5-099b-72b5-acf4-ae4eebdcc927", "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 only includes drugs approved by the Center for Drug Evaluation and Research (CDER). 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.", "Orphan drugs are drugs that treat rare diseases or conditions, affecting fewer than 200,000 people in the US. As developing these drugs would not be profitable for drug companies on their own, the Orphan Drug Act provides incentives such as tax credits and market exclusivity for these drugs.", "Fast track is a process created by the FDA to help drugs for serious conditions reach patients more quickly when there is an unmet medical need. It allows drug developers to have more frequent meetings with the FDA and to submit parts of their application as they\u2019re ready, instead of waiting until everything is complete.", "Accelerated Approval is an FDA pathway that allows certain drugs for serious conditions to be approved based on earlier evidence \u2014 such as lab results or imaging \u2014 instead of waiting for direct proof of clinical benefit.", "Breakthrough Therapy is a designation the FDA can give drugs when early clinical evidence suggests that a new treatment may offer substantial improvement over existing options for a serious illness.", "A Qualified Infectious Disease Product is a drug intended to treat serious or life-threatening bacterial or fungal infections. The FDA grants this status under a law called the GAIN Act to encourage new antibiotics and antifungals.", "Designations can be overlapping; a drug can receive multiple designations or no designation at all.", "The data does not include [generics](#dod:generic-drug) or reformulations of existing drugs."], "dimensions": {"years": {"values": [{"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}]}, "entities": {"values": [{"id": 371799, "name": "Accelerated approvals", "code": null}, {"id": 371802, "name": "All new drug approvals", "code": null}, {"id": 371800, "name": "Breakthrough therapy approvals", "code": null}, {"id": 371798, "name": "Fast track approvals", "code": null}, {"id": 371797, "name": "Orphan drug approvals", "code": null}, {"id": 371801, "name": "Qualified infectious disease product approvals", "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"}}]}