Quick answers
- What is Somatrogon-ghla used for?
- The FDA-approved label (Ngenla, Pfizer Laboratories Div Pfizer Inc, August 14, 2026) says: “NGENLA is indicated for the treatment of pediatric patients aged 3 years and older who have growth failure due to an inadequate secretion of endogenous growth hormone. NGENLA is a human growth hormone analog indicated for treatment of pediatric patients aged 3 years and older who have growth failure due to inadequate secretion of endogenous growth hormone.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Somatrogon-ghla 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 Somatrogon-ghla?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Somatrogon-ghla been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Somatrogon-ghla?
- 1 company lists prescription products of Somatrogon-ghla in the FDA NDC Directory, including Pfizer Laboratories Div Pfizer Inc.
What Somatrogon-ghla is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
NGENLA is indicated for the treatment of pediatric patients aged 3 years and older who have growth failure due to an inadequate secretion of endogenous growth hormone. NGENLA is a human growth hormone analog indicated for treatment of pediatric patients aged 3 years and older who have growth failure due to inadequate secretion of endogenous growth hormone.
— FDA label: Ngenla, Pfizer Laboratories Div Pfizer Inc, effective August 14, 2026. 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 | Injection, solution |
|---|---|
| Route | Subcutaneous |
| Prescription products | 2 in the FDA NDC Directory |
| Brand names | Ngenla |
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.
- Pfizer Laboratories Div Pfizer Inc2 products
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA761184 NGENLA | Pfizer Ireland Pharmaceuticals | June 27, 2023 | 4, latest April 29, 2026 2026: Labeling · 2025: Labeling · 2024: Manufacturing (CMC) |
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) | 2644517, 2644523, 2644526, 2644529 |
|---|---|
| SPL set ID of the quoted label | 06dce529-b741-4a1b-8842-3ad77be6e308 |
| FDA labels (SPL) | 1 |
| FDA applications | BLA761184 |
| Active ingredients (FDA) | SOMATROGON |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Ngenla, Pfizer Laboratories Div Pfizer Inc, effective August 14, 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 →