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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Satumomab pendetide
Trade Name: Oncoscint CR/OV
Date Designated: 09/25/1989
Orphan Designation: Detection of ovarian carcinoma.
Orphan Designation Status: Designated/Approved
Cytogen Corporation
600 College Road East
Princeton, New Jersey 08540
United States

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

Marketing approved:

1 Generic Name: Satumomab pendetide
Trade Name: Oncoscint CR/OV
Marketing Approval Date: 12/29/1992
Approved Labeled Indication: For determining the extent and location of extraphepatic malignant disease in patients with known colorectal and ovarian cancer.
Exclusivity End Date: 12/29/1999 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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