Prescription medicine
Rozanolixizumab Brand names: Rystiggo
Rozanolixizumab (Rystiggo) is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the rozanolixizumab FDA label on DailyMed (effective January 20, 2026); every rozanolixizumab label on DailyMed.
Highlights of the record
FDA label of January 20, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageRYSTIGGO is indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.
Forms and strengths
- 140 mg/ml
Injection (solution).
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 1,026 through July 30, 2026
What is rozanolixizumab used for?
From the label: indications and usageRYSTIGGO is indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive. RYSTIGGO (rozanolixizumab-noli) is a neonatal Fc receptor blocker indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.
FDA pharmacologic class: Neonatal Fc Receptor Blocker.
Source: FDA drug label (RYSTIGGO), UCB, Inc., effective January 20, 2026 (SPL set 3c0eb8c2-c042-4954-b451-3baa77f5e6d1), via openFDA; the full label on DailyMed
Is there a generic for rozanolixizumab (Rystiggo)?
No generic rozanolixizumab is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for rozanolixizumab?
The FDA Adverse Event Reporting System holds 1,026 reports that list rozanolixizumab among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 18 are coded as a death and 339 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other neonatal Fc receptor blockers
- the pharmacologic class, with prices and generics
- Rozanolixizumab side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other