Which of these is FDA approved?

4 recorded statuses, not two

The whole column, in the words each record uses. One status names the product it belongs to, because more than one tesamorelin label is in circulation and they are not identical; another is scoped to the uses these molecules are actually sold for. Read together they are the difference between a drug you can be handed at a pharmacy and one a compounder makes to order.

not approved

CJC-1295 (no DAC), CJC-1295 + DAC — 2 of 5, each with the document behind it below

withdrawn

Sermorelin — 1 of 5, with the document behind it below

approved (Egrifta SV)

Tesamorelin — 1 of 5, with the document behind it below

no approval for these uses

Ipamorelin — 1 of 5, with the document behind it below

4 recorded statuses that a search result flattens into one. They describe 4 genuinely different histories, and the rest of this page is what each of them means.

Withdrawn is not never approved

Sermorelin is recorded as withdrawn, and that is not a polite way of saying unapproved. It held approvals. The document behind the cell is a Federal Register notice, and what a notice of withdrawal records is an ending rather than a refusal: the approvals were withdrawn after the products were discontinued, and the notice states that the withdrawal was not for reasons of safety or effectiveness.

So “never approved” would be false about it, and “withdrawn” is the word the record supports. The status is the whole of what the record says. Why the products were discontinued is a commercial history no document here tells, and guessing at it would be adding a story to the notice.

Document

Determination That GEREF (Sermorelin Acetate) Injection, 0.5 Milligrams Base/Vial and 1.0 Milligrams Base/Vial, and GEREF (Sermorelin Acetate) Injection, 0.05 Milligrams Base/Amp, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

Published in

Federal Register, volume 78, number 42, pages 14095–14096, Notice

Date on the document

published 2013-03-04, signed 2013-02-26

Identifier

78 FR 14095, FR Doc. 2013-04827, Docket No. FDA-2012-P-1071

The one live approval, and the label it comes out of

Tesamorelin is recorded as approved (Egrifta SV) — and the parenthesis is the part that took work. The cell names the product its document is for, because there is more than one tesamorelin label in circulation and they differ. A cell reading a bare “approved” would be true of a molecule and vague about which marketed product a reader could actually be handed.

Document

EGRIFTA SV (tesamorelin) for injection, for subcutaneous use — full prescribing information

Published in

DailyMed structured product label, National Library of Medicine

Date on the document

label face date: Revised 03/2024; label version published 2026-07-31

Identifier

SPL set id 3d783378-b02d-4f19-99dd-0fc91a042224, Initial U.S. Approval 2010

What that product is approved for is deliberately not on this page. It is not a field in this site’s records, and an indication written from memory beside a real label is the kind of hand-typed clinical fact that is one edit from false and looks perfectly authoritative while it is. The label itself is linked in the sources below; it states its own indication, and that is the right place to read it. The indication, the population it was tested in and the three half-lives on three labels are read from those labels on what is tesamorelin.

What “not approved” covers, and what it does not

CJC-1295 (no DAC), CJC-1295 + DAC; Ipamorelin are the 3 with no approval behind them, and the two records do not say it in the same way. For the two CJC-1295 forms the review states it outright: neither variant is approved as a therapeutic agent by the FDA or the EMA. For ipamorelin the same review is narrower, and the cell follows it rather than rounding up: apart from tesamorelin in its HIV indication, none of these compounds carries approval for the performance and appearance uses they are sold for.

The distinction matters if you are reading a seller’s page. A molecule with no approval at all and a molecule with no approval for this are in the same place at the checkout, and neither of them is a product the FDA has reviewed for what the menu says it does.

What a regulatory record does not tell you

None of the 4 statuses on this page is a verdict about a molecule. An unapproved molecule is not thereby a bad one, an approved one is not thereby better for you, and a withdrawn approval is not a safety finding unless the document says it is — the one on this site says in terms that it was not. A regulatory status is a fact about a filing, and reading it onto a person is a clinician’s job rather than a comparison site’s.

And what the shelves have done with it

The column and the shelves are not the same shape, and putting all 5 molecules on one scale is the thing a molecule-first site can do that a seller-first one cannot. What follows is how far each of them reaches across the 14 seller records here — not a market share, and not a claim about demand. It is a count of menus, read once each, on the dates printed beside their figures.

2 of these 5 reach no seller record here at all, and the reason is not that nobody sells them. It is that 0 of the 19 listings here resolve to either CJC-1295 record, while 2 name a CJC-1295 product without saying which form is inside — so those listings cannot be filed under either record without asserting the thing the seller withheld. That is the subject of which CJC-1295 are you buying?

Sources

2 of the 4 statuses rest on primary government documents — a Federal Register notice and a product label — and the rest on the peer-reviewed literature. All of them are below, with the date printed on each.