FDA Approves New Dosing Options for Hizentra® The U.S. Food and Drug Administration (FDA) has approved the administration options for CSL Behring's Hizentra® (Immune Globulin Subcutaneous (Human), 20% Liquid) to include the ability to individualize therapy with flexible dosing—treatment at regular intervals from daily to once every two weeks (biweekly)—for people with primary immunodeficiency (PI). More information may be found here. FDA Approves Second Octagam Manufacturing Site The U.S. Food and Drug Administration (FDA) has approved a new manufacturing site in Vienna, Austria for the production of Octagam 10% (Immune Globulin Intravenous (Human) 10% (100 mg/mL) Liquid Preparation), which became available in the U.S. in October 2014. The therapy can now be produced at FDA-licensed facilities in both Stockholm, Sweden and Vienna, which should facilitate product availability for patients. Hospira Recalls Sodium Chloride Injection Hospira has initiated a voluntary nationwide recall of one lot of 0.9% Sodium Chloride Injection, USP, 250 mL (NDC 0409-7983-02, Lot 44-002-JT, Expires 1AUG2016) to the user level due to one confirmed customer report of particulate in a single unit. The company has identified the particulate as a human hair, sealed in the bag at the additive port area. This lot was distributed nationwide from September 2014 through November 2014. More information may be found here.
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