Novartis and Roche have worked to expand Xolair's reach with new formulations and approvals in new diseases. In 2014, the drug won the FDA's blessing to treat chronic hives—specifically, chronic ...

Use XOLAIR exactly as prescribed by a healthcare provider. For children 12 years of age and older, XOLAIR prefilled syringe may be self-injected under adult supervision.

The Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Xolair ® (omalizumab; Genentech and Novartis) prefilled syringe for self-injection ...

During the first period, study participants (N=619) were randomly assigned to receive omalizumab-igec 300mg, Xolair 300mg, omalizumab-igec 150mg, or Xolair 150mg for 12 weeks.

Before starting self-injection with Xolair prefilled syringe, the patient must have no prior history of anaphylaxis and be closely observed by a healthcare provider for at least three injections ...

The Food and Drug Administration (FDA) has accepted for filing the supplemental Biologics License Application (sBLA) for a new self-administration option for omalizumab (Genentech and Novartis ...

If approved, Xolair prefilled syringe would become available for either self-administration by select patients or administration by their caregivers. A decision on approval is anticipated by Q1 2021.

Before they can self-administer the prefilled syringe, providers must observe patients for hypersensitivity after at least three injections in a health care setting, according to the press releases.

While working to improve administration of Xolair, the U.S. syringe formulation patents for which expire in 2021 and 2025, Novartis has also been advancing a potential successor to the drug.

Use XOLAIR exactly as prescribed by a healthcare provider. For children 12 years of age and older, XOLAIR prefilled syringe may be self-injected under adult supervision.

Xolair, which was first approved in the U.S. in 2003 to treat allergic asthma and is now also approved for chronic idiopathic urticaria and nasal polyps, previously required a healthcare ...

For children 12 years of age and older, XOLAIR prefilled syringe may be self-injected under adult supervision. For children 6 to 11 years of age, XOLAIR prefilled syringe should be injected by a ...