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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: pralatrexate
Date Designated: 05/03/2010
Orphan Designation: Treatment of advanced or metastatic transitional cell carcinoma of the urinary bladder
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Acrotech Biopharma LLC
279 Princeton Hightstown Road
East Windsor, New Jersey 08520
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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