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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Dexrazoxane
Trade Name: Zinecard
Date Designated: 12/17/1991
Orphan Designation: For the prevention of cardiomyopathy associated with doxorubicin administration.
Orphan Designation Status: Designated/Approved
Pharmacia & Upjohn
7000 Portage Road
Kalamazoo, Michigan 49001
United States

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

Marketing approved:

1 Generic Name: Dexrazoxane
Trade Name: Zinecard
Marketing Approval Date: 05/26/1995
Approved Labeled Indication: Cardiomyopathy associated with doxorubicin administration in women with metastatic breast cancer who have received a cumulative dose of 300mg/m2.
Exclusivity End Date: 05/26/2002 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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