By the PeptideFactSheets Editorial Team. Claims are source-checked under our editorial policy; clinician review is identified 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 Products can be discontinued, approvals can be withdrawn, and safety communications can add context.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 its latest 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