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Data

New drugs approved in the United States, by designations

See all data and research on:
Medicine & Biotechnology

What you should know about this indicator

  • 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’re 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 — such as lab results or imaging — 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 or reformulations of existing drugs.
New drugs approved in the United States, by designations
The annual number of new drugs approved by the Center for Drug Evaluation and Research (CDER), that fall under each designation, including , , , , and .
Source
US Food and Drug Administration (2025) – with major processing by Our World in Data
Last updated
July 16, 2025
Next expected update
July 2026
Date range
1985–2024
Unit
approvals

Sources and processing

This data is based on the following sources

US Food and Drug Administration – CDER New Molecular Entity (NME) Drug and New Biologic Approvals

This dataset provides a listing of all new drugs approved from 1985 – 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.

This 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.

Retrieved on
July 16, 2025
Retrieved from
https://www.fda.gov/drugs/drug-approvals-and-databases/compilation-cder-new-molecular-entity-nme-drug-and-new-biologic-approvals
Citation
This is the citation of the original data obtained from the source, prior to any processing or adaptation by Our World in Data. To cite data downloaded from this page, please use the suggested citation given in Reuse This Work below.
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)

This dataset provides a listing of all new drugs approved from 1985 – 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.

This 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.

Retrieved on
July 16, 2025
Retrieved from
https://www.fda.gov/drugs/drug-approvals-and-databases/compilation-cder-new-molecular-entity-nme-drug-and-new-biologic-approvals
Citation
This is the citation of the original data obtained from the source, prior to any processing or adaptation by Our World in Data. To cite data downloaded from this page, please use the suggested citation given in Reuse This Work below.
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)

How we process data at Our World in Data

All data and visualizations on Our World in Data rely on data sourced from one or several original data providers. Preparing this original data involves several processing steps. Depending on the data, this can include standardizing country names and world region definitions, converting units, calculating derived indicators such as per capita measures, as well as adding or adapting metadata such as the name or the description given to an indicator.

At the link below you can find a detailed description of the structure of our data pipeline, including links to all the code used to prepare data across Our World in Data.

Read about our data pipeline

Reuse this work

  • All data produced by third-party providers and made available by Our World in Data are subject to the license terms from the original providers. Our work would not be possible without the data providers we rely on, so we ask you to always cite them appropriately (see below). This is crucial to allow data providers to continue doing their work, enhancing, maintaining and updating valuable data.
  • All data, visualizations, and code produced by Our World in Data are completely open access under the Creative Commons BY license. You have the permission to use, distribute, and reproduce these in any medium, provided the source and authors are credited.

Citations

How to cite this page

To cite this page overall, including any descriptions, FAQs or explanations of the data authored by Our World in Data, please use the following citation:

“Data Page: New drugs approved in the United States, by designations”, part of the following publication: Tuna Acisu, Saloni Dattani, Fiona Spooner, Veronika Samborska, Hannah Ritchie, and Max Roser (2025) - “Medicine and Biotechnology”. Data adapted from US Food and Drug Administration. Retrieved from https://data-childlabor-ilounicef.owid.pages.dev:8789/20260318-114526/grapher/new-drugs-approved-in-the-united-states-by-designations.html [online resource] (archived on March 18, 2026).

How to cite this data

In-line citationIf you have limited space (e.g. in data visualizations), you can use this abbreviated in-line citation:

US Food and Drug Administration (2025) – with major processing by Our World in Data

Full citation

US Food and Drug Administration (2025) – with major processing by Our World in Data. “New drugs approved in the United States, by designations” [dataset]. US Food and Drug Administration, “CDER New Molecular Entity (NME) Drug and New Biologic Approvals” [original data]. Retrieved April 14, 2026 from https://data-childlabor-ilounicef.owid.pages.dev:8789/20260318-114526/grapher/new-drugs-approved-in-the-united-states-by-designations.html (archived on March 18, 2026).

Download

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Download the data shown in this chart as a ZIP file containing a CSV file, metadata in JSON format, and a README. The CSV file can be opened in Excel, Google Sheets, and other data analysis tools.

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Data API

Use these URLs to programmatically access this chart's data and configure your requests with the options below. Our documentation provides more information on how to use the API, and you can find a few code examples below.

Data URL (CSV format)
https://data-childlabor-ilounicef.owid.pages.dev/grapher/new-drugs-approved-in-the-united-states-by-designations.csv?v=1&csvType=full&useColumnShortNames=false
Metadata URL (JSON format)
https://data-childlabor-ilounicef.owid.pages.dev/grapher/new-drugs-approved-in-the-united-states-by-designations.metadata.json?v=1&csvType=full&useColumnShortNames=false

Code examples

Examples of how to load this data into different data analysis tools.

Excel / Google Sheets
=IMPORTDATA("https://data-childlabor-ilounicef.owid.pages.dev/grapher/new-drugs-approved-in-the-united-states-by-designations.csv?v=1&csvType=full&useColumnShortNames=false")
Python with Pandas
import pandas as pd
import requests

# Fetch the data.
df = pd.read_csv("https://data-childlabor-ilounicef.owid.pages.dev/grapher/new-drugs-approved-in-the-united-states-by-designations.csv?v=1&csvType=full&useColumnShortNames=false", storage_options = {'User-Agent': 'Our World In Data data fetch/1.0'})

# Fetch the metadata
metadata = requests.get("https://data-childlabor-ilounicef.owid.pages.dev/grapher/new-drugs-approved-in-the-united-states-by-designations.metadata.json?v=1&csvType=full&useColumnShortNames=false").json()
R
library(jsonlite)

# Fetch the data
df <- read.csv("https://data-childlabor-ilounicef.owid.pages.dev/grapher/new-drugs-approved-in-the-united-states-by-designations.csv?v=1&csvType=full&useColumnShortNames=false")

# Fetch the metadata
metadata <- fromJSON("https://data-childlabor-ilounicef.owid.pages.dev/grapher/new-drugs-approved-in-the-united-states-by-designations.metadata.json?v=1&csvType=full&useColumnShortNames=false")
Stata
import delimited "https://data-childlabor-ilounicef.owid.pages.dev/grapher/new-drugs-approved-in-the-united-states-by-designations.csv?v=1&csvType=full&useColumnShortNames=false", encoding("utf-8") clear