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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: vigabatrin
Trade Name: Vigafyde
Date Designated: 10/12/2022
Orphan Designation: Treatment of Infantile Spasms
Orphan Designation Status: Designated/Approved
Pyros Pharmaceuticals, Inc.
2001 Route 46, Suite 310
Parsippany, New Jersey 07054
United States

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

Marketing approved:

1 Generic Name: vigabatrin
Trade Name: Vigafyde
Marketing Approval Date: 06/17/2024
Approved Labeled Indication: as monotherapy for the treatment of infantile spasms in pediatric patients 1 month to 2 years of age for whom the potential benefits outweigh the potential risk of vision loss
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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