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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: Ready-to-use vigabatrin oral liquid
Date Designated: 10/12/2022
Orphan Designation: Treatment of Infantile Spasms
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
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.

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.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