Drugs

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Enhertu feature graphic - women sitting in hospital bed

Drug approved for breast cancer with a certain genetic profile

Dec 20 - Expands options for adult patients with cancer that has spread

Woman laying in bed with her hand on her head

FDA approves drug for the acute treatment of migraines

Dec 23 - For migraines with or without aura in adults

Drug Safety Communication Gabapentinoids

Serious breathing problems with gabapentin & pregabalin

Dec 19 - When used with opioids & meds that slow breathing, in elderly

Drug Information, Safety, and Availability

Medication Guides, Drug Safety Communications, Shortages, Recalls

Drug Approvals and Databases

Drugs@FDA, Orange Book, National Drug Code, Recent drug approvals

Drug Development and Review Process

Drug applications, submissions, manufacturing, and small business help

Guidance, Compliance, and Regulatory Information

Guidances, warning letters, drug compounding, registration and listing

Regulatory Science and Research

CDER research programs, initiatives, and resources

Emergency Preparedness

Prepare and respond to natural disasters, nuclear and chemical attacks

Updates, News, and Events

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About the Center for Drug Evaluation and Research (CDER)

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Consumers and Patients

Find drug information. Report drug side effects. Learn how to buy, use, and dispose of unused drugs. Attend a public meeting.

Health Care Professionals

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Industry

Search drug databases. Find guidance, submission, user fee, and meeting information. Get small business assistance. Find jobs at FDA.

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 Development Tools Qualification Program

Using scientific and technical innovations for better drug development

21st Century Cures at CDER

Bringing innovative and advanced medicines to patients faster

Expanded Access | Compassionate Use

Providing access to investigational drugs outside of clinical trials

Drug Shortages

Search the database, learn about root causes and potential solutions

Dec 19

FDA warns about serious breathing problems with seizure and nerve pain medicines gabapentin (Neurontin, Gralise, Horizant) and pregabalin (Lyrica, Lyrica CR)

Dec 04

FDA Updates and Press Announcements on NDMA in Zantac (ranitidine)

Nov 07

FDA Updates and Press Announcements on Angiotensin II Receptor Blocker (ARB) Recalls (Valsartan, Losartan, and Irbesartan)

Drug Safety Announcements

Center

Dec 30

Aurobindo Pharma USA, Inc. Issues Voluntary Nationwide Recall of Mirtazapine Tablets Lot Number 03119002A3 Due to Label Error on Declared Strength

Dec 18

Lannett Issues Voluntary Nationwide Recall of Levetiracetam Oral Solution, 100mg/Ml Due to Microbial Contamination

Dec 17

Glenmark Pharmaceuticals Inc., USA Voluntarily Recalls All Unexpired Lots of its Ranitidine Tablets and Ceases Distribution, Due to Possible Presence of N-nitrosodimethylamine (NDMA) Impurity

Center

Dec 23

FDA approves new treatment for adults with migraine

Dec 20

FDA approves new treatment option for patients with HER2-positive breast cancer who have progressed on available therapies

More Press Announcements

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

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(855) 543-3784

(301) 796-3400

Hours Available

CDER Division of Drug Information

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