Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
  • Print
  • Share
  • E-mail
-
Generic Name: Fludarabine phosphate oral tablets
Trade Name:
Date Designated: 12/18/2007
Orphan Designation: Treatment of B-cell chronic lymphocytic leukemia
Orphan Designation Status: Designated/Approved
Sanofi-Aventis U.S., Inc.
55 Corproate Drive
P. O. Box 5925
Bridgewater, New Jersey 08807
United States

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

Marketing approved:

1 Generic Name: Fludarabine phosphate oral tablets
Trade Name:
Marketing Approval Date: 12/18/2008
Approved Labeled Indication: Treatment of adult patients with B-cell chronic lymphocytic leukemia (CLL) whose disease has not responded to or has progressed during or after treatment with at least one standard alkylating-agent containing regimen
Exclusivity End Date: 12/18/2015 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
-
-