Quick answers
- What is Nipocalimab-aahu used for?
- The FDA-approved label (Imaavy, Janssen Biotech, Inc., August 21, 2026) says: “IMAAVY is a neonatal Fc receptor blocker indicated for the treatment of: generalized myasthenia gravis (gMG) in adult and pediatric patients 12 years of age and older who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Nipocalimab-aahu 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 Nipocalimab-aahu?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Nipocalimab-aahu been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started September 23, 2026 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Nipocalimab-aahu?
- 1 company lists prescription products of Nipocalimab-aahu in the FDA NDC Directory, including Janssen Biotech, Inc..
What Nipocalimab-aahu is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
IMAAVY is a neonatal Fc receptor blocker indicated for the treatment of: generalized myasthenia gravis (gMG) in adult and pediatric patients 12 years of age and older who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive. …
— FDA label: Imaavy, Janssen Biotech, Inc., effective August 21, 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, concentrate |
|---|---|
| Route | Intravenous |
| Prescription products | 2 in the FDA NDC Directory |
| Brand names | Imaavy |
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.
- Janssen Biotech, Inc.2 products
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA761430 IMAAVY | Janssen Biotech | April 29, 2025 | 1, latest August 24, 2026 2026: Efficacy |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
September 23, 2026 · Class II · Ongoing · D-0016-2027
Presence of particulate matter.
IMAAVY (nipocalimab-aahu) Injection, 300 mg /1.62 mL (185 mg/mL) per single-dose vial, For Intravenous Infusion After Dilution, Rx only, Manufactured by: Janssen Biotech, Inc., Horsham, PA 19044. NDC: 57894-800-01 — J&J INNOVATIVE MEDICINE
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 2712699, 2712706, 2712708, 2712709 |
|---|---|
| SPL set ID of the quoted label | 8886274c-f2b2-48af-85c1-2f90bfe304b8 |
| FDA labels (SPL) | 1 |
| FDA applications | BLA761430 |
| Active ingredients (FDA) | NIPOCALIMAB |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Imaavy, Janssen Biotech, Inc., effective August 21, 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 →