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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Hydroxyurea
Trade Name: Droxia
Date Designated: 10/01/1990
Orphan Designation: Treatment of patients with sickle cell anemia as shown by the presence of hemoglobin S.
Orphan Designation Status: Designated/Approved
Bristol-Myers Squibb Pharmaceutical Research Institute
P.O. Box 4000
Princeton, New Jersey 08543
United States

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

Marketing approved:

1 Generic Name: Hydroxyurea
Trade Name: Droxia
Marketing Approval Date: 02/25/1998
Approved Labeled Indication: To reduce the frequency of painful crises and to reduce the need for blood transfusions in adult patients with sickle cell anemia with recurrent moderate to severe painful crises (generally at least 3 during the preceding 12 months).
Exclusivity End Date: 02/25/2005 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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