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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: nipocalimab-aahu
Trade Name: Imaavy
Date Designated: 02/11/2021
Orphan Designation: Treatment of myasthenia gravis
Orphan Designation Status: Designated/Approved
Janssen Research & Development, LLC
1125 Trenton-Harbourton Road
Titusville, New Jersey 08560
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: nipocalimab-aahu
Trade Name: Imaavy
Marketing Approval Date: 04/29/2025
Approved Labeled Indication: 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
Exclusivity End Date: TBD  
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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