Xolair Prefilled Syringe Formulation Gets FDA Approval

Xolair PFS is expected to be available in both a 75mg/0.5mL and 150mg/mL dosage strengths by the end of 2018.
Xolair PFS is expected to be available in both a 75mg/0.5mL and 150mg/mL dosage strengths by the end of 2018.

The Food and Drug Administration (FDA) has approved a prefilled syringe formulation of Xolair (omalizumab; Genentech) for the treatment of allergic asthma and chronic idiopathic urticaria. 

Xolair Prefilled Syringe (PFS) is expected to be available in both a 75mg/0.5mL and 150mg/mL dosage strengths by the end of 2018. Currently, the drug is available as a 150mg per vial strength powder for subcutaneous injection. The PFS formulation eliminates the need to reconstitute the solution before administration; however, both formulations should still be administered by a healthcare professional.

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Xolair, an anti-IgE antibody, is indicated for patients ≥6 years of age with moderate to severe persistent asthma who have a positive skin test, or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids. It is also approved for the treatment of adults and adolescents ≥12 years of age with chronic idiopathic urticaria who remain symptomatic despite H1 antihistamine treatment.

For more information visit Xolair.com.