NovoSeven RT Receives FDA Approval for Larger Vial Size

Horizons in Hemophilia, November 2010

By Leigh Carpenter, RPh, Chief Pharmacist 

Novo Nordisk announced the U.S. Food and Drug Administration (FDA) has approved an 8mg vial size for NovoSeven RT, the company’s recombinant factor VIIa product.  Previous sizes still available are 1mg, 2mg and 5mg.  This new 8mg vial will allow easier administration for patients using larger doses, with possibly fewer vials to reconstitute per infusion.  Also, the FDA 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).