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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Thyrotropin alpha
Trade Name: Thyrogen
Date Designated: 02/24/1992
Orphan Designation: As an adjunct in the diagnosis of thyroid cancer.
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: Thyrotropin alpha
Trade Name: Thyrogen
Marketing Approval Date: 11/30/1998
Approved Labeled Indication: As an adjunctive diagnostic tool for serum thyroglobulin (Tg) testing with or without radioiodine imaging in the follow-up of patients with thyroid cancer.
Exclusivity End Date: 11/30/2005 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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