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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  hydroxycarbamide (hydroxyurea)
Trade Name:  Siklos
Date Designated:  07/24/2013
Orphan Designation:  Treatment of sickle cell disease in patients under 18 years of age
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  12/21/2017 
Approved Labeled Indication:  To reduce the frequency of painful crises and to reduce the need for blood transfusions in pediatric patients, 2 years of age and older, with sickle cell anemia with recurrent moderate to severe painful crisis
Exclusivity End Date:    12/21/2024 
Exclusivity Protected Indication* :  To reduce the frequency of painful crises and to reduce the need for blood transfusions in pediatric patients, 2 years of age amd older, with sickle cell anemia with recurrent moderate to severe painful crisis
Addmedica Laboratories
37 rue de Caumartin
Paris
France

The sponsor address listed is the last reported by the sponsor to OOPD.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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