Novartis/Roche Xolair Prefilled Syringe Receives FDA Approval

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On April 12, the FDA approved a supplementary biological product license application for Xolair (omalizumab) prefilled syringes, which can be used for self-injection and are suitable for all indications approved in the United States.

Xolair is a biological agent that targets and blocks immunoglobulin E (IgE) for the treatment of moderate to severe persistent allergic asthma, chronic idiopathic urticaria (CIU) and nasal polyps.

This medicine is a prescription injection drug that is administered by subcutaneous injection.

Xolair was approved for the treatment of nasal polyps in December last year as an add-on therapy to intranasal corticosteroids (INC) for the treatment of severe chronic rhino-sinusitis with nasal polyps that cannot be adequately controlled by INC.

Before starting self-injection using Xolair prefilled syringes, the patient must have no history of allergies and be closely observed by a healthcare provider for at least three injections, and no allergic reactions have occurred.

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