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Drugs

The Center for Drug Evaluation and Research (CDER) ensures that safe and effective drugs are available to improve the health of the people in the United States

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Regulating and Approving Drugs Video Series

FDA uses science and data to ensure that approved drugs are of a high quality, safe, and effective. Learn more about the FDA’s role in reviewing, approving, and monitoring drugs in the latest videos that are now available in Spanish.

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Consumer Contact Information Drug Alerts and Statements What's New Related to Drugs

Search our databases:

Drugs@FDA

Find information about most FDA-approved prescription, generic, and over-the-counter drug products.

Drug Shortages

Find information about drug shortages caused by manufacturing and quality problems, delays, and discontinuations.

Orange Book

The Orange Book identifies drug products approved by FDA on the basis of safety and effectiveness.

News

Graphic with decorative stars and red and white capsules in the background.
FDA approves first generic of Flovent HFA for treatment of asthma

FDA approves first generic of inhalation aerosol for asthma

Drug provides maintenance treatment for patients aged 4 years and older
The cover of the ARC Program's Year Three Annual Report. The title is set against a blue gradient background that features a stylized, translucent image of a zebra's head and stripes in the upper right corner.

Accelerating Rare disease Cures (ARC) Program publishes annual report

Program is a driver of innovation in rare disease drug development
Man with short black hair in rust colored cable stitch sweater standing at picture window and looking away from camera.

FDA approves novel treatment for hemophilia A or B

Drug can be given once every two months to prevent or reduce bleeding episodes

Navigate the Drugs Section

Center

Upcoming Drug-related Events

Priority Areas & Initiatives

Opioids

Reducing the impact of opioid misuse and abuse

Generics

Ensuring access to safe, affordable, and effective generic drugs

Warning Letters

Warning and Notice of Violation Letters to Pharmaceutical Companies

Guidances

FDA's current thinking on drug development and review activities

Drug Shortages

Search the database, learn about root causes and potential solutions

Resources

Information for consumers, health professionals, and industry

CENTER FOR DRUG EVALUATION AND RESEARCH

Office of Communications
10001 New Hampshire Ave
Hillandale Building, 4th Fl
Silver Spring, MD 20993

druginfo@fda.hhs.gov

Toll Free
(855) 543-3784
(301) 796-3400

Hours Available

CDER Division of Drug Information

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@FDA_Drug_Info

Your source for the latest drug information.
Know the moment it happens.

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