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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: PEG-glucocerebrosidase
Date Designated: 12/09/1992
Orphan Designation: For use as chronic enzyme replacement therapy in patients with Gaucher's disease who are deficient in glucocerebrosidase.
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
National Institute of Mental Health, NIH
49 Convent Dr. MSC4405
Bldg. 49, Room B1EE16
Bethesda, Maryland 20892
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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