Last month Novo Nordisk announced that the U.S. Food and Drug Administration (FDA) had approved NovoSeven® RT, the company’s recombinant factor VIIa product, in an 8 mg (milligram) vial size.
NovoSeven® RT is indicated for the treatment of bleeding episodes in hemophilia A or B patients with inhibitors to factor VIII (FVIII) or factor IX (FIX) and in patients with acquired hemophilia, and for prevention of bleeding in surgical interventions or invasive procedures in hemophilia A or B patients with inhibitors to FVIII or FIX. It is also used for patients with congenital factor VII deficiency in the treatment of bleeding episodes and in the prevention of bleeding in surgical interventions or invasive procedures.
The new 8-mg vial allows a rapid initiation and administration of the medication for patients who need a larger dose. In addition, FDA has also approved the extension of shelf life for all vial sizes from 24 months to 36 months at room temperature (at or below 77 degrees Fahrenheit).
Source: Novo Nordisk news release dated August 10, 2010