FDA grants approval of Xolair (omalizumab) prefilled syringe formulation

Roche announced today that the U.S. Food and Drug Administration (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. (Source: Roche Investor Update)

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