Research & Development
Novartis' Xolair prefilled syringe supplemental Biologics License Application receives US FDA approval
13 April 2021 -

Switzerland-based Novartis announced on Monday that it has received the United States Food and Drug Administration (FDA)approval for the supplemental Biologics License Application for its Xolair (omalizumab) prefilled syringe for self-injection in appropriate patients across all approved US indications.

The product is claimed to be the only US FDA-approved biologic aimed at targeting and blocking immunoglobulin E (IgE) for the treatment of moderate to severe persistent allergic asthma, chronic idiopathic urticaria (CIU) and nasal polyps.

Novartis Pharmaceuticals Corporation and Genentech, a member of the Roche Group, collaborated to develop and co-promote the product in the United States.