Search Orphan Drug Designations and Approvals
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Generic Name: | Coagulation factor VIIa (recombinant) | ||||||||||||||||
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Trade Name: | NovoSeven | ||||||||||||||||
Date Designated: | 06/18/2004 | ||||||||||||||||
Orphan Designation: | Prevention of bleeding episodes in patients with hemophilia A or B, with or without inhibitors | ||||||||||||||||
Orphan Designation Status: | Designated/Approved | ||||||||||||||||
Sponsor: |
Novo Nordisk, Inc. 100 Overlook Center Suite 200 Princeton, New Jersey 08540 United States 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 VIIa (recombinant) |
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Trade Name: | NovoSeven | |
Marketing Approval Date: | 08/12/2005 | |
Approved Labeled Indication: | Prevention of bleeding in surgical interventions or invasive procedures in hemophilia A or B patients with inhibitors to Factor VIII or Factor IX | |
Exclusivity End Date: | 08/12/2012 | |
Exclusivity Protected Indication* : | ||
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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