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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: PEGylated, Engineered, Human Cystathionine gamma-Lyase
Date Designated: 10/22/2020
Orphan Designation: Treatment of Homocystinuria
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
The University of Texas at Austin on behalf of the Board of Regents of the University of Texas System
3925 W. Braker Lane Suite 1.9A (R3500)
Austin, Texas 78759
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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