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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: Ifosfamide
Trade Name: Ifex
Date Designated: 01/20/1987
Orphan Designation: Treatment of testicular cancer.
Orphan Designation Status: Designated/Approved
Bristol-Myers Squibb Pharmaceutical Research Institute
5 Research Parkway, P.O. Box 5100
Wallingford, Connecticut 06492
United States

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

Marketing approved:

1 Generic Name: Ifosfamide
Trade Name: Ifex
Marketing Approval Date: 12/30/1988
Approved Labeled Indication: In combination with certain other approved antineoplastic agents, for third line chemotherapy in the treatment of germ cell testicular cancer.
Exclusivity End Date: 12/30/1995 
Exclusivity Protected Indication* :  

*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.