Quick answers
- What is Histrelin acetate used for?
- The FDA-approved label (Supprelin La, Endo USA, Inc., September 25, 2025) says: “SUPPRELIN LA (histrelin acetate) subcutaneous implant is indicated for the treatment of children with central precocious puberty (CPP). Children with CPP (neurogenic or idiopathic) have an early onset of secondary sexual characteristics (earlier than 8 years of age in females and 9 years of age in males). They also show a significantly advanced bone age that can result in diminished adult height attainment. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Histrelin acetate have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Histrelin acetate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Histrelin acetate been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Histrelin acetate?
- 1 company lists prescription products of Histrelin acetate in the FDA NDC Directory, including Endo USA, Inc..
What Histrelin acetate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
SUPPRELIN LA (histrelin acetate) subcutaneous implant is indicated for the treatment of children with central precocious puberty (CPP). Children with CPP (neurogenic or idiopathic) have an early onset of secondary sexual characteristics (earlier than 8 years of age in females and 9 years of age in males). They also show a significantly advanced bone age that can result in diminished adult height attainment. …
— FDA label: Supprelin La, Endo USA, Inc., effective September 25, 2025. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
Forms and how it is given
| Dosage forms | Implant |
|---|---|
| Route | Subcutaneous |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Supprelin La |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Endo USA, Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA022058 SUPPRELIN LA | Endo Operations | May 3, 2007 | 12, latest September 23, 2025 2025: Labeling · 2022: Labeling · 2019: Labeling |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 1294641, 1740437 |
|---|---|
| SPL set ID of the quoted label | d8fb000e-3cc9-4803-b71d-2cc597661977 |
| FDA labels (SPL) | 1 |
| FDA applications | NDA022058 |
| Active ingredients (FDA) | HISTRELIN ACETATE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Supprelin La, Endo USA, Inc., effective September 25, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →