By the PeptideFactSheets Editorial Team. Use the source links to verify status, evidence, risks, and unknowns; our editorial policyexplains the boundaries. Clinician review appears only when a named reviewer is shown.
What FDA approval means
FDA approval means the agency reviewed an application for a particular drug product and determined that its benefits outweigh its known and potential risks for the labeled use when used according to that label. Manufacturing, quality, and labeling are part of the review.
Approval is for a specific use
A molecule may appear in different brands, strengths, or formulations. Each product label describes who it is for, what it treats, and important safety information. Approval for one condition does not approve every online claim about the ingredient.
Why status can change
Labels can gain new indications or warnings. Products can be discontinued, approvals can be withdrawn, and safety communications can add context. That is why each fact sheet links to primary sources readers can verify directly.
How to verify current status
Search the official Drugs@FDA database, open the exact product record, and read the product label. For active research, verify the study record at ClinicalTrials.gov.
Examples in this library
Semaglutide, tirzepatide, and liraglutide appear in products approved for defined metabolic uses. Tesamorelin has a narrow HIV-lipodystrophy indication. These examples illustrate why product and use matter.
What approval does not mean
- Risk-free or right for every person
- Approved for every possible goal
- Equivalent to a compounded or online product
- Proof that a related experimental molecule works
- A substitute for an individual clinician's judgment
Sources for this guide
These official and educational sources support the general regulatory and research concepts explained on this page. For a specific medicine, use the fact sheet's product-level sources.
- 1fdaFDA: is it really FDA approved?
Explains what FDA approval means for an intended use and why compounded drugs are not FDA approved.
- 2fdaFDA: about Drugs@FDA
Describes the approved-product records, labels, approval letters, and other documents available in Drugs@FDA.
- 3fdaFDA: the drug review process
Details how clinical, manufacturing, labeling, and safety information are assessed during review.
- 4fdaFDA: compounding and the FDA — questions and answers
Clarifies the difference between compounded drugs, FDA-approved drugs, and approved generics.