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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: Sabril
Date Designated: 06/12/2000
Orphan Designation: Treatment of infantile spasms.
Orphan Designation Status: Designated/Approved
H. Lundbeck A/S
Four Parkway North
Deerfield, Illinois 60015
United States

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

Marketing approved:

1 Generic Name: vigabatrin
Trade Name: Sabril
Marketing Approval Date: 08/21/2009
Approved Labeled Indication: For infantile spasms (IS) - 1 month to 2 years of age.
Exclusivity End Date: 08/21/2016 
Exclusivity Protected Indication* :  

*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.