FDA Label Search
The drug labeling and other information has been reformatted to make it easier to read but its content has neither been altered nor verified by FDA. The drug labeling on this Web site may …
Unapproved Drugs | FDA - U.S. Food and Drug Administration
Many health care professionals and patients are unaware that some of the drugs prescribed are not FDA approved. FDA permits some unapproved prescription drugs to be marketed if: there is...
Understanding Unapproved Use of Approved Drugs "Off Label"
Has your healthcare provider ever talked to you about using an FDA-approved drug for an unapproved use (sometimes called an “off-label” use) to treat your disease or medical …
Frequently Asked Questions about Labeling for Prescription Medicines - FDA
Labeling for prescription medicines is required for all FDA-approved prescription medicines. Such labeling is: If acceptable, approved by the FDA. If the labeling for a new medicine...
Reserve concomitant prescribing of these drugs for patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients …
FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss
Oct 2, 2024 · FDA has warned companies that have illegally sold unapproved drugs containing semaglutide, tirzepatide or retatrutide that are falsely labeled “for research purposes” or “not …
FDALabel: Full-Text Search of Drug Product Labeling | FDA
Web-based application to search labeling documents of FDA-approved drug products. What is Included in Drug Labeling? The FDALabel Database is a web-based application used to …
To report SUSPECTED ADVERSE REACTIONS, contact Flexion Therapeutics, Inc. at 1-844-FLEXION (353-9466) or FDA at 1-800-FDA 1088 or www.fda.gov/medwatch. See 17 for …
Drug Approvals and Databases | FDA - U.S. Food and Drug Administration
Additional topics include: approved REMS, drug shortages, and the Orange book. ... FDA Online Label Repository; FDA’s Labeling Resources for Human Prescription Drugs; Content current …
Is It Really 'FDA Approved'? - U.S. Food and Drug Administration
May 10, 2022 · The FDA doesn’t approve the food label, including the Nutrition Facts label. The FDA does not approve individual food labels before food products can be marketed.