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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: Alpha-galactosidase A
Date Designated: 07/20/1990
Orphan Designation: Treatment of Fabry's disease.
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Desnick, Robert J. M.D.
The Mount Sinai School Of Medicine
Fifth Avenue at 100th Street, Box 1203
New York, New York 10029
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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