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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Pegademase bovine
Trade Name: Adagen
Date Designated: 05/29/1984
Orphan Designation: For enzyme replacement therapy for ADA deficiency in patients with severe combined immunodeficiency.
Orphan Designation Status: Designated/Approved
Sigma-tau Pharmaceuticals, Inc.
9841 Washingtonian Blvd
Suite 500
Gaithersburg, Maryland 20878
United States

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

Marketing approved:

1 Generic Name: Pegademase bovine
Trade Name: Adagen
Marketing Approval Date: 03/21/1990
Approved Labeled Indication:
Exclusivity End Date: 03/21/1997 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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