logo
Plus   Neg
Share
Email

Genentech : FDA Accepts Application For Xolair For Self-Administration Across All Indications

Genentech, a member of the Roche Group (RHHBY), said Thursday that the U.S. Food and Drug Administration accepted the company's supplemental Biologics License Application or sBLA for a new self-administration option for Xolair or omalizumab across all approved U.S. indications.

If approved, Xolair prefilled syringe would become available for either self-administration by select patients or administration by their caregivers.

The company expects to receive approval by the first-quarter 2021.

In the U.S., Xolair is currently approved for administration by a healthcare provider in a healthcare setting, and is the only approved biologic designed to target and block immunoglobulin E (IgE) for the treatment of patients with moderate to severe persistent allergic asthma and chronic idiopathic urticaria (CIU).

In the U.S., Genentech and Novartis Pharmaceuticals Corporation work together to develop and co-promote Xolair.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
The European Commission said Friday that it has signed a deal with Sanofi and GlaxoSmithKline to secure up to 300 million doses of their potential COVID-19 vaccine. Acella Pharmaceuticals recalled certain lots of hypothyroidism medication NP Thyroid in the form of tablets due to super potency, the U.S. Food and Drug Administration said in a statement. The company is recalling one lot of 15mg and one lot of 120mg of NP Thyroid that are packaged in 100 count bottles in strengths of 15 mg, and 120 mg, with expiration dates between October 2020 and November 2020. Walmart announced its decision to raise wages for around 165,000 hourly associates across all its U.S. stores starting October, and introduce a team-based operating model in Supercenters. In a tweet, the retail giant said, "Today we're introducing new leadership roles and cross-training opportunities, giving our associates more ways to grow their careers."
Follow RTT