Posted by Michael Wonder on 01 Oct 2018
FDA approves Genentech's Xolair (omalizumab) pre-filled syringe formulation
28 September 2018 - The 75 mg/0.5 mL and 150 mg/1 mL single-dose pre-filled syringes are expected to be available by the end of 2018.
Genentech announced today that the U.S. FDA has approved 75 mg/0.5 mL and 150 mg/1 mL single-dose pre-filled syringes for Xolair (omalizumab) as an additional formulation for both allergic asthma and chronic idiopathic urticaria indications.
Xolair is currently available in a 150 mg single-dose vial with lyophilised, sterile powder for reconstitution.
