Sermorelin had FDA-approved Geref products for specific pediatric growth and diagnostic uses. Approval was withdrawn in 2009 after discontinuation; FDA later determined the products were not withdrawn for safety or effectiveness reasons. This history does not approve current compounded products or anti-aging uses.[1]
- Jurisdiction
- United States
- Product
- Historical GEREF sermorelin products
- Indication
- Former specified pediatric growth-hormone deficiency and diagnostic indications
- Record date
- 2026-09-08
- Historical US product status, not a claim of present commercial availability.
- The record date shown is the date through which this pass checked that the described status still holds. It is not the date of the governing Federal Register determination, which is 4 March 2013 and is shown on the source record. The check covered Federal Register notices and the Drugs@FDA application record for both former Geref applications; it did not survey every kind of FDA activity concerning sermorelin.
Inspection history
Clinical review: not reviewed by a qualified clinician.
· Independently inspected the listed passages; replaced or qualified inherited assertions. No qualified clinical review has occurred.
· Independent fresh reinspection for the deep-evidence pass: reopened every cited source at its passages via NCBI E-utilities / DailyMed / accessdata.fda.gov / govinfo.gov / Wayback Machine mirror, checked Europe PMC correction/retraction metadata where applicable, and confirmed the claim's wording against the primary text. Disposition: supported within the stated scope. No qualified clinical review.
· Added a note explaining what the shown record date means for this claim, after a reviewer found it is the only regulatory claim whose record date is a document date rather than the evidence cutoff. No date, source or scientific statement changed.
· Currency check for the regulatory-currency batch. This claim recorded the governing document's date rather than the evidence cutoff because the pass had not established that no later FDA action existed. That check has now been done: no later Federal Register notice on these applications was found between the determination and the cutoff, and Drugs@FDA still shows both former applications as discontinued with the not-for-safety-or-effectiveness determination attached. The recorded date is therefore moved to the cutoff, in line with every other regulatory claim, and the reader-facing note is rewritten to say what the date now means and what the check did and did not cover. No source or scientific statement changed. Independent editorial review pending; no qualified clinical review.