Read the scope
Approved use
Approval belongs to a particular medicine and a named use.
Read both parts when comparing a claim about care.
- FDA
- The U.S. Food and Drug Administration reviews medicines to decide whether they can be approved.
Start with the label
As of September 28, 2026, tesamorelin’s labelled use is to reduce excess belly fat in adults with HIV and lipodystrophy.
HIV means human immunodeficiency virus; lipodystrophy means the body stores fat in a changed pattern.
The label does not cover general weight loss.
The label leaves unanswered how tesamorelin affects the heart and blood vessels over the long term.
- Off-label
- A use outside the purpose covered by the drug’s approval.
What “off-label” tells you
A tesamorelin use outside the purpose on its label is called off-label.
That word does not tell you how strong the evidence is.
Ask which human studies support the proposed use and what they leave unanswered.
What other approaches could address that concern?
- Registered
- An entry in FDA records, without establishing that the medicine has FDA approval.
Check the product as well as the purpose
As of September 26, 2026, a company or drug being listed as “FDA registered” does not mean the drug is FDA approved.
Request the medicine’s precise name along with its approved drug label.