Which of these is FDA approved?

3 recorded statuses, and one of them rests on no document

The whole column, grouped by what it actually says. The grouping is on the recorded string exactly as written — nothing is case-folded and no parenthetical is trimmed — because a status that names the product its document is for and a status that does not are two different records, and merging them would hide the difference this page exists to show.

not approved

Ipamorelin, CJC-1295 (no DAC), CJC-1295 + DAC — 3 of 5, and Ipamorelin carries no document for it [needs citation]

withdrawn

Sermorelin — 1 of 5, traced to a document

approved (Egrifta SV)

Tesamorelin — 1 of 5, traced to a document

3 recorded statuses that a search result flattens into one. They describe 3 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Withdrawn is not never approved

Sermorelin is recorded as withdrawn, and that is not a polite way of saying unapproved.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Register notice, and what a notice of withdrawal records is an ending rather than a refusal: the approvals were withdrawn after the products were discontinued, and the notice states that the withdrawal was not for reasons of safety or effectiveness.

So “never approved” would be false about it, and “withdrawn” is the word the record supports. This site prints the status and stops: why the products were discontinued is a commercial history it has not verified, and guessing at it would be adding a story to a document that does not tell one.

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Base/Vial and 1.0 Milligrams Base/Vial, and GEREF (Sermorelin Acetate) Injection, 0.05 Milligrams Base/Amp, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness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 status this site cannot show you a document for

Ipamorelin, CJC-1295 (no DAC), CJC-1295 + DAC are the 3 recorded as not having an approval here. Ipamorelin’s cell is the one that carries a marker, and the marker is not a doubt about the value. It is this site saying it has not read a document that states the thing the cell claims.

The difficulty is scope. Peer-reviewed reviews read for this site do say these compounds are not approved for the indications those reviews describe, and one of them puts them in what it calls a regulatory grey zone. A cell that says it flatly is making a wider claim than any of those sentences, and the wider claim is the one this site has not found a document for. So the marker stays until it does, rather than being cleared by attaching the most plausible-looking reference to it.

What a regulatory record does not tell you

None of the 3 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 18 listings this site holds 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

Every regulatory figure on this page is traced to a document below or marked as untraced. 2 of the 3 statuses rest on primary government documents — a Federal Register notice and a product label — and the rest on the peer-reviewed literature.

Citation status, counted from the records behind this page rather than typed: 3 of 21 pharmacological figures on it are recorded in this site’s data but not yet traced to a published source, and they are marked [needs citation] where they appear. Where the writing below restates one of those figures, it rests on the same unsourced record. The open sourcing work is listed in the repository’s content to-do. This line counts itself down as sources land.