nipocalimab-aahu

FDA Drug Profile — IMAAVY

nipocalimab-aahu is listed in the FDA National Drug Code directory with 2 NDC codes, marketed under brand name including IMAAVY. Available dosage form: injection, solution, concentrate.

Drug Details

Generic Name
nipocalimab-aahu
Brand Names
IMAAVY
Application Number
BLA761430
Sponsor
Janssen Biotech, Inc.
NDC Codes
2
Dosage Forms
INJECTION, SOLUTION, CONCENTRATE
Routes
INTRAVENOUS
Active Ingredients
NIPOCALIMAB

Indications and Usage

1 INDICATIONS AND USAGE IMAAVY is 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. 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. ( 1 )