Approved Product vs Approved Indication

Why approval is for a specific use, with a U.S. example of one active ingredient in two products, and how stem-cell, exosome and device approvals are narrower than marketing suggests.

Content last updated October 22, 2026. This page has not been medically reviewed.

Quick answer

A regulator does not approve a product in the abstract. It approves a specific product for specific uses, in specific people. The approved use is called the indication. When you hear "it is FDA approved," the next question is "approved for what?" This page uses United States rules and labels as the example; other countries have their own systems, and this is not legal advice.

Example: one active ingredient, two products, different indications

Semaglutide is the active ingredient in several products from the same company. These are the indications in the FDA-approved prescribing information as posted on DailyMed (National Library of Medicine), read 2026-10-22. Labels change, so check the current version. This is an illustration of the rule, not advice about any medicine.

	Ozempic (injection)	Wegovy
Label version read	Published June 10, 2026 [4]	Published June 30, 2026 [5]
Blood sugar	As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes [4]	Not listed as an indication
Weight	Not listed as an indication	Reduce excess body weight and maintain weight reduction long term in adults and children aged 12 and older with obesity, and in adults with overweight plus a weight-related condition [5]
Heart	In adults with type 2 diabetes and established cardiovascular disease, reduce the risk of major adverse cardiovascular events [4]	In adults with established cardiovascular disease and either obesity or overweight, reduce the risk of major adverse cardiovascular events [5]
Kidney	Reduce the risk of sustained eGFR decline, end-stage kidney disease and cardiovascular death in adults with type 2 diabetes and chronic kidney disease [4]	Not listed
Liver	Not listed	Noncirrhotic MASH with moderate to advanced fibrosis in adults, under accelerated approval based on improvement of MASH and fibrosis [5]

The Wegovy label covers both an injection and tablets. [5] The Wegovy label also says using it with other semaglutide-containing products or other GLP-1 receptor agonists is not recommended. [5] The point is that the same ingredient has different approved uses depending on the product. Whether any prescription medicine is right for you is a decision for you and your prescriber.

Same idea in other fields

Stem cells. The FDA said (consumer alert dated July 22, 2020; page current April 2024) that the only FDA-approved stem cell products consist of blood-forming stem cells from umbilical cord blood, approved for disorders that affect the production of blood, and not approved for other uses. [6]
Exosomes. The same FDA alert says there are currently no FDA-approved exosome products. [6] Check the FDA for any change since that page was posted. See Regulatory Status of Regenerative Products by Product and Indication.
Devices. A 510(k) clearance finds a device substantially equivalent to a legally marketed device. [7] A premarket approval is a separate, more stringent route for the highest-risk devices. [8] Neither turns marketing slogans into evidence.
Software and apps. Check the exact product and its stated purpose. See Regulatory Status of Digital Health Products.

How to check an approval

Write down the exact product name and the exact use being promised.
Look up the official label or regulator record for that product, not a similar one.
Compare the promised use and the people in the trial with the label's indication.
If they do not match, treat the use as unproven and ask your clinician what evidence exists.

Related guides: Approved vs Off-Label vs Investigational Use (peptide examples) and Claim Check: "FDA Registered" vs Product Approval.

Frequently asked questions

What is an indication?

It is the disease, condition or purpose a regulator has approved a product to address. For U.S. prescription drugs it is stated in the Indications and Usage section of the label. [2]

If a drug is approved, can it be marketed for any use?

No. The label lists the diseases and conditions the drug is approved to treat. [1] For other uses, FDA has not determined the drug is safe and effective. [1]

Does a clinic's use of an approved product make the clinic's version approved?

No. Approval attaches to the product and its labeled use. Ask for the label and compare it with what is being offered.

Are all stem cell or exosome treatments approved?

According to the FDA page read, the only approved stem cell products are cord-blood-derived blood-forming stem cells for blood-production disorders, and no exosome products are approved. [6]

Where can I read a label?

DailyMed, run by the U.S. National Library of Medicine, posts prescribing information; the example above came from there. [4]

More details: evidence, limits and cautions

The details behind this page: cautions, limits of the evidence and where sources disagree. Open any note to read it.

Where the approved use is written

For prescription medicines, the label (prescribing information) lists the specific diseases and conditions the drug is approved to treat. [1] FDA rules require the Indications and Usage section to state that the drug is indicated for the treatment, prevention, mitigation, cure or diagnosis of a recognized disease or condition. [2] Where an indication rests on a surrogate endpoint (a measure standing in for a clinical outcome), the label must describe the limits of usefulness and uncertainty. [2] Labeling describes the basis for approval and how best to use the drug. [3]

Five ways "approved" can be narrower than it sounds

Product. One brand, formulation or route is approved; a similar-sounding product may not be. Do not carry an approval over to a look-alike.
Indication. A drug approved for one condition is not approved for others. Use outside the label is called off-label, covered in Off-Label Use Explained.
Population. The Wegovy label above separates adults from children aged 12 and older. [5]
Strength of evidence. An accelerated approval can rest on a surrogate measure and may be contingent on a later confirmatory trial. [5]
Marketing claims. FDA has not determined a drug is safe and effective for an unapproved use. [1]

References

U.S. Food and Drug Administration (FDA), Understanding Unapproved Use of Approved Drugs "Off Label" (page current as of 02/05/2018). Read 2026-10-22.
Electronic Code of Federal Regulations, 21 CFR 201.57, Specific requirements on content and format of labeling for human prescription drug and biological products. Read 2026-10-22.
U.S. FDA, The Drug Development Process, Step 4: FDA Drug Review (page current as of 01/04/2018). Read 2026-10-22.
U.S. National Library of Medicine, DailyMed, OZEMPIC (semaglutide) injection, prescribing information, Novo Nordisk, version published Jun 10, 2026. Read 2026-10-22.
U.S. National Library of Medicine, DailyMed, WEGOVY (semaglutide) injection and tablets, prescribing information, Novo Nordisk, version published Jun 30, 2026. Read 2026-10-22.
U.S. FDA, Consumer Alert on Regenerative Medicine Products Including Stem Cells and Exosomes (dated July 22, 2020; page current as of 04/09/2024). Read 2026-10-22.
U.S. FDA, Premarket Notification 510(k). Read 2026-10-22.
U.S. FDA, Premarket Approval (PMA). Read 2026-10-22.

Education, not medical advice. This page is for general information. It does not diagnose or treat any condition and is not a substitute for care from a qualified health professional. Natural does not automatically mean safe. Ask a clinician or pharmacist before changing your care, especially if you take medication, are pregnant or breastfeeding, or have a health condition.