Vaccines, Blood & Biologics
NovoSeven
Proper Name: Coagulation Factor VIIa (Recombinant)
Tradename: NovoSeven
Manufacturer: Novo Nordisk Inc, License #1261
Date: March 25, 1999
Indication: Treatment of bleeding episodes in hemophilia A or B patients with inhibitors to Factor VIII or Factor IX
March 25, 1999 Approval Letter
Summary Basis for Approval (PDF - 589 KB)
Date: October 13, 2006
Indication: Treatment of bleeding episodes and for the prevention of bleeding in surgical interventions or invasive procedures in patients with acquired hemophilia
October 13, 2006 Approval Letter
Contact Us
Consumer Affairs Branch (CBER)
- (800) 835-4709
- (301) 827-1800
- ocod@fda.hhs.gov
Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Food and Drug Administration
1401 Rockville Pike
Suite 200N/HFM-47
Rockville, MD 20852-1448