Diario

Sermorelin acetate in the record

Sermorelin has a paper trail, and the trail has an end date. The ingredient in the discontinued prescription product was sermorelin acetate. The listing on this shop is a research vial of that salt. Those are not the same object. This note quotes the pages that were opened. It does not turn a discontinued label into instructions.

The catalog line is the shop fact, stated once up front so the history is not asked to carry the price. The name is "Sermorelin 5mg." The full name is "Sermorelin acetate." One vial is $35. The catalog has no multi-vial pack for this slug. The page is Sermorelina 5 mg.

Sermorelin acetate, in the chemical record

PubChem's record for sermorelin acetate carries a description from the NCI Thesaurus. The page opened for this article is https://pubchem.ncbi.nlm.nih.gov/compound/Sermorelin-Acetate. The NCI text there reads:

"Sermorelin Acetate is the acetate salt form of sermorelin, a synthetic, amidated 29-amino acid peptide that corresponds to the amino-terminal segment of the naturally occurring human growth hormone-releasing hormone (GHRH). Sermorelin acetate directly stimulates the pituitary gland, resulting in release of growth hormone leading to increased plasma growth hormone, which is responsible for many biological processes and counteracts growth hormone deficiency."

That is a thesaurus description of a substance. It is not a direction to take anything. The same PubChem page has a class line, drawn from Drugs@FDA and the Orange Book, that says "FDA approved drugs." That line is not a current marketing status. The FDA pages below say discontinued. This article follows those pages, not the class line. No half-life and no extra mechanism are added from memory.

What the FDA record says sermorelin was approved to do

The history is in a Federal Register notice the FDA published on March 4, 2013, document 2013-04827. The page opened is https://www.govinfo.gov/content/pkg/FR-2013-03-04/html/2013-04827.htm.

The notice says GEREF (Sermorelin Acetate) injection, 0.5 mg base/vial and 1.0 mg base/vial, "is the subject of NDA 20-443, held by EMD Serono, and initially approved on September 26, 1997." It says GEREF (Sermorelin Acetate) injection, 0.05 mg base/amp, "is the subject of NDA 19-863, held by EMD Serono, and initially approved on December 28, 1990."

It states the old indications in one sentence: "GEREF (Sermorelin Acetate) injection, 0.5 mg base/vial and 1.0 mg base/vial, is indicated for the treatment of idiopathic growth hormone deficiency (GHD) in children with growth failure, and GEREF (Sermorelin Acetate) injection, 0.05 mg base/amp, is indicated for evaluating the ability of the somatotroph of the pituitary gland to secrete growth hormone."

Those sentences describe Geref as it was labeled. They are not a use for a 5 mg research vial. The strengths identify the discontinued products. They are not a chart, and this note will not scale them or describe how the old product was given.

Drugs@FDA, opened for both applications, matches the holder and the dates. NDA 019863, EMD SERONO, is GEREF, active ingredient SERMORELIN ACETATE, EQ 0.05MG BASE/AMP, dosage form INJECTABLE;INJECTION, original approval 12/28/1990. NDA 019863. NDA 020443, EMD SERONO INC, is two GEREF rows, EQ 0.5MG BASE/VIAL and EQ 1MG BASE/VIAL, both INJECTABLE;INJECTION, original approval 09/26/1997. NDA 020443.

Sermorelin, as the FDA lists it now

Both Drugs@FDA pages list Marketing Status as Discontinued for every Geref row on those applications. The strength column on each row also carries this note: "Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons."

The 2013 notice is that determination. It says EMD Serono, in a letter dated July 11, 2008, notified FDA that the 0.05 mg base/amp product "was being discontinued," and FDA moved it to the "Discontinued Drug Product List" section of the Orange Book. In a letter dated December 2, 2008, EMD Serono notified FDA that the 0.5 mg and 1.0 mg vial product "was being discontinued" and requested withdrawal of NDA 20-443. In a letter dated December 12, 2008, EMD Serono requested withdrawal of NDA 19-863. "In the Federal Register of May 19, 2009 (74 FR 23407), FDA announced that it was withdrawing approval of NDA 19-863 and NDA 20-443, effective June 18, 2009."

The notice then says FDA determined that both products "were not withdrawn from sale for reasons of safety or effectiveness." It says the agency "will continue to list" them in the "Discontinued Drug Product List" section of the Orange Book. It also says that list "delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness," and that abbreviated applications referring to those Geref products "may be approved" if they meet the other legal requirements.

Read that in order. The applications were approved in 1990 and 1997. The maker told FDA in 2008 that it was discontinuing the products. FDA withdrew those approvals effective June 18, 2009. In 2013 FDA said the withdrawal from sale was not for safety or effectiveness, and left the products on the discontinued list. A sentence about abbreviated applications that meet every other requirement is not an approval of a product on a shelf. The marketing status on the pages opened here is Discontinued. This note does not call sermorelin currently approved. It also does not claim to have searched every later application. The Geref record that was opened is a discontinued record. A research listing does not revive it.

This sermorelin vial is not a Geref pen

The research vial is not a Geref pen. It is not a Geref ampule, and it is not a Geref vial. Geref was the EMD Serono product under NDA 19-863 and NDA 20-443. Those approvals were withdrawn. What this shop sells is one 5 mg vial of sermorelin acetate, the catalog's full name, at $35. The labeled amount is 5 mg. That number is a fill target for a research vial, not a dose inherited from the 0.05 mg, 0.5 mg, or 1.0 mg Geref presentations.

Purity is at least 99 percent. Fill is within 10 percent of the labeled weight. The material is for adults 21 and older. It is not for people or animals. This shop is not a pharmacy. This page is not medical advice. A discontinued prescription brand is not restored by printing the old name next to a new bottle.

No preparation steps are included. The Federal Register notice was used for status, holder, dates, and the old indication sentences.

What the outlets did not write

The CNN, Fox, Guardian, NPR, Scientific American, Verge, Reuters, and Johns Hopkins pages opened for What CNN, Fox, and the other outlets wrote do not name sermorelin. This note will not invent a cable-news line for it. The record above is the discontinued Geref file.

Sources on sermorelin

NCI Thesaurus description as carried on PubChem, Sermorelin Acetate. https://pubchem.ncbi.nlm.nih.gov/compound/Sermorelin-Acetate.

FDA, Federal Register, March 4, 2013, "Determination That GEREF (Sermorelin Acetate) Injection… Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness," FR Doc. 2013-04827. https://www.govinfo.gov/content/pkg/FR-2013-03-04/html/2013-04827.htm.

Drugs@FDA, NDA 019863, GEREF, sermorelin acetate, marketing status Discontinued. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=019863.

Drugs@FDA, NDA 020443, GEREF, sermorelin acetate, marketing status Discontinued. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020443.

Catalog price checked against `catalog.py` before publication: sermorelin-5mg, name "Sermorelin 5mg," full name "Sermorelin acetate," 3500 cents, no pack.

Research vials. 21 and older. Not for people or animals.

Viales de investigación. 21 años o más. No es para personas ni animales. No es consejo médico.