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....

Continue reading this story and get 24/7 access to Contract Pharma for FREE


Already a subscriber? Sign in

Keep Up With Our Content. Subscribe To Contract Pharma Newsletters