FDA approves single-dose prefilled syringes for Xolair as a new formulation for allergic asthma and urticaria .- Novartis

Genentech, a member of the Roche Group announced that the FDA has approved 75 mg/0.5 mL and 150 mg/1 mL single-dose prefilled syringes (PFS) for Xolair (omalizumab) as an additional formulation for both allergic asthma and chronic idiopathic urticaria (CIU) indications. The new Xolair PFS formulation is expected to be available by the end of this year for the first time in the U.S. Xolair is currently available in a 150 mg single-dose vial with lyophilized, sterile powder for reconstitution.

The Xolair PFS eliminates the need for healthcare providers to procure Sterile Water for Injection (SWFI) and reconstitute Xolair before administering the medicine.