Vaccines, Blood & Biologics
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NovoSevenRT
STN: BL 103665
Proper Name: Coagulation Factor VIIa (Recombinant)
Tradename: NovoSevenRT
Manufacturer: Novo Nordisk Inc, License #1261
Indication:
- Treatment of bleeding episodes in hemophilia A or B with inhibitors and in acquired hemophilia (1.1)
- Prevention of bleeding in surgical interventions or invasive procedures in hemophilia A or B with inhibitors and in acquired hemophilia (1.2)
- Treatment of bleeding episodes in congenital FVII deficiency (1.3)
- Prevention of bleeding in surgical interventions or invasive procedures in congenital FVII deficiency (1.4)
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Supporting Documents
January 15, 2010 Approval Letter - NovoSevenRT
Package Insert Updated: To include a Black Box Warning on serious thrombotic adverse events associated with the use of NovoSeven® RT outside labeled indications.May 9, 2008 Approval Letter - NovoSevenRT
Indication: Room temperature stable formulation.
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Related Information
FDA Online Label Repository
Search this database for drug labeling and other information. The content has not been altered or verified by the FDA and may not be the labeling on currently distributed products or identical to the labeling that is approved.FDA Approves New Formulation of Coagulation Therapy
Press Release: May 9, 2008
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Contact FDA
(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)
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
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