Notice: Function _load_textdomain_just_in_time was called incorrectly. Translation loading for the wordpress-seo domain was triggered too early. This is usually an indicator for some code in the plugin or theme running too early. Translations should be loaded at the init action or later. Please see Debugging in WordPress for more information. (This message was added in version 6.7.0.) in /var/www/html/wp-includes/functions.php on line 6260 FDA Approves Hizentra Shelf Life Extension | Contract Pharma

What are you searching for?

Sign in
Breaking News, Trials & Filings

FDA Approves Hizentra Shelf Life Extension

CSL Behring received approval from the FDA for its sBLA to extend the shelf life of Hizentra, Immune Globulin Subcutaneous (Human), 20% Liquid, from 18 months to 24 months.

Author Image

By: Tim Wright

Editor-in-Chief, Contract Pharma

CSL Behring received approval from the FDA for its sBLA to extend the shelf life of Hizentra, Immune Globulin Subcutaneous (Human), 20% Liquid, from 18 months to 24 months. Hizentra is the only 20% subcutaneous immunoglobulin (SCIg) approved in the U.S. It’s also the first SCIg in the U.S. that can be stored at room temperature.

Hizentra is indicated for the treatment of primary immunodeficiency (PI). PI is a group of disorders, usually genetic, that result from a dysfunctional immune system. This condition prevents patients from fighting off infections caused by common germs. Stabilized with L-proline, a naturally occurring amino acid, Hizentra can be stored at room temperature (up to 25°C / 77°F) for as long as 24 months and is always ready to use without warming.

“CSL Behring continually enhances the products in our broad portfolio based on what we know patients and their healthcare providers need and want,” said Robert Lefebvre, vice president and general manager, U.S. Commercial Operations at CSL Behring. “The ability to store Hizentra without refrigeration for up to two years is an innovation that can positively impact busy and active patients managing their primary immunodeficiency at home or in any setting that is convenient for them.”

Add us as a preferred source on Google

Get the latest Contract Pharma news, insights and analysis in your Google Search and AI experiences.

Add Contract Pharma as a preferred source on Google (opens in a new tab)

Keep Up With Our Content. Subscribe To Contract Pharma Newsletters