Search Orphan Drug Designations and Approvals
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Generic Name: | Coagulation factor X (human) | ||||||||||||||||
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Trade Name: | COAGADEX | ||||||||||||||||
Date Designated: | 11/08/2007 | ||||||||||||||||
Orphan Designation: | Treatment of hereditary factor X deficiency | ||||||||||||||||
Orphan Designation Status: | Designated/Approved | ||||||||||||||||
Sponsor: |
Bio Products Laboratory Limited Dagger Lane Elstree, Hertfordshire United Kingdom The sponsor address listed is the last reported by the sponsor to OOPD. |
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Marketing approved: |
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1 | Generic Name: | Coagulation factor X (human) |
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Trade Name: | COAGADEX | |
Marketing Approval Date: | 10/20/2015 | |
Approved Labeled Indication: | Treatment of adults and adolescents (aged 12 years and above) with hereditary Factor X deficiency for on-demand treatment and control of bleeding episodes and perioperative management of bleeding in patients with mild hereditary Factor X deficiency | |
Exclusivity End Date: | 10/20/2022 | |
Exclusivity Protected Indication* : | Treatment of adults and adolescents (aged 12 years and above) with hereditary Factor X deficiency for on-demand treatment and control of bleeding episodes and perioperative management of bleeding in patients with mild hereditary Factor X deficiency | |
2 | Generic Name: | Coagulation factor X (human) |
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Trade Name: | COAGADEX | |
Marketing Approval Date: | 09/21/2018 | |
Approved Labeled Indication: | COAGADEX is indicated in adults and children with hereditary Factor X deficiency for routine prophylaxis to reduce the frequency of bleeding episodes; on-demand treatment and control of bleeding episodes; and perioperative management of bleeding in patients with mild and moderate hereditary Factor X deficiency. | |
Exclusivity End Date: | 09/21/2025 | |
Exclusivity Protected Indication* : | Coagadex is indicated for routine prophylaxis to reduce the frequency of bleeding episodes in adults and children with hereditary Factor X deficiency; on-demand treatment and control of bleeding episodes in children under the age of 12 years with hereditary Factor X deficiency; perioperative management of bleeding in children under the age of 12 years with mild hereditary factor X deficiency; perioperative management of bleeding in adults and children with moderate hereditary Factor X deficiency | |
3 | Generic Name: | Coagulation factor X (human) |
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Trade Name: | Coagadex | |
Marketing Approval Date: | 04/14/2023 | |
Approved Labeled Indication: | in adults and children with hereditary Factor X deficiency for routine prophylaxis to reduce the frequency of bleeding episodes; on-demand treatment and control of bleeding episodes; and perioperative management of bleeding in patients with mild, moderate, and severe hereditary Factor X deficiency | |
Exclusivity End Date: | 04/14/2030 | |
Exclusivity Protected Indication* : | perioperative management of bleeding in adults and children with severe hereditary Factor X deficiency | |
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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