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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: Valrubicin
Trade Name: Valstar
Date Designated: 05/23/1994
Orphan Designation: Treatment of carcinoma in situ of the urinary bladder.
Orphan Designation Status: Designated/Approved
Anthra Pharmaceuticals, Inc.
103 Carnegie Center, Suite 102
Princeton, New Jersey 08540
United States

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

Marketing approved:

1 Generic Name: Valrubicin
Trade Name: Valstar
Marketing Approval Date: 09/25/1998
Approved Labeled Indication: For intravesical therapy of BCG-refractory carcinoma in situ of the urinary bladder in patients for whom immediate cystectomy would be associated with unacceptable morbidity or mortality.
Exclusivity End Date: 09/25/2005 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.