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: | 09/10/2004 | ||||||||||||||||
Orphan Designation: | Treatment of bleeding episodes in patients with congenital factor VII deficiency | ||||||||||||||||
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: | 07/11/2005 | |
Approved Labeled Indication: | Treatment of bleeding episodes in patients with Factor VII Deficiency | |
Exclusivity End Date: | 07/11/2012 | |
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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