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 |
| Sponsor: |
Addmedica Laboratories 37 rue de Caumartin Paris France The sponsor address listed is the last reported by the sponsor to OOPD. |
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