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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Imiglucerase
Trade Name: Cerezyme
Date Designated: 11/05/1991
Orphan Designation: Replacement therapy in patients with types I, II, and III Gaucher's disease.
Orphan Designation Status: Designated/Approved
Genzyme Corporation
One Kendall Square
Cambridge, Massachusetts 02139
United States

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

Marketing approved:

1 Generic Name: Imiglucerase
Trade Name: Cerezyme
Marketing Approval Date: 05/23/1994
Approved Labeled Indication: Enzyme replacement therapy in patients with type I Gaucher's disease.
Exclusivity End Date: 05/23/2001 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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