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 - Category: Pharmaceuticals Source Type: news