Quick answers
- What is Mecasermin used for?
- The FDA-approved label (Increlex, Eton Pharmaceuticals, Inc., May 18, 2026) says: “INCRELEX (mecasermin) injection is indicated for the treatment of growth failure in pediatric patients 2 years of age and older with severe primary IGF- 1 deficiency or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH. Limitations of use: INCRELEX is not a substitute to GH for approved GH indications. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Mecasermin have a boxed warning?
- No. None of the 2 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Mecasermin?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Mecasermin been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Mecasermin?
- 2 companies list prescription products of Mecasermin in the FDA NDC Directory, including Eton Pharmaceuticals, Inc. and Ipsen Biopharmaceuticals, Inc..
What Mecasermin is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
INCRELEX (mecasermin) injection is indicated for the treatment of growth failure in pediatric patients 2 years of age and older with severe primary IGF- 1 deficiency or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH. Limitations of use: INCRELEX is not a substitute to GH for approved GH indications. …
— FDA label: Increlex, Eton Pharmaceuticals, Inc., effective May 18, 2026. Read the full label on DailyMed →
The FDA has 2 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
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.
0 of 2 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection · Injection, solution |
|---|---|
| Route | Subcutaneous |
| Prescription products | 2 in the FDA NDC Directory |
| Brand names | Increlex |
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.
- Eton Pharmaceuticals, Inc.1 product
- Ipsen Biopharmaceuticals, Inc.1 product
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA021839 INCRELEX | Ipsen Inc | August 30, 2005 | 11, latest July 9, 2025 2025: Labeling · 2024: Efficacy · 2023: 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) | 604806, 615882 |
|---|---|
| SPL set ID of the quoted label | d5b2b0e1-c523-468d-9a0b-4ae4e4a8dbce |
| FDA labels (SPL) | 2 |
| FDA applications | BLA021839 |
| Active ingredients (FDA) | MECASERMIN |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Increlex, Eton Pharmaceuticals, Inc., effective May 18, 2026; 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 →