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Hizentra FDA Approval History

FDA Approved: Yes (First approved March 4, 2010)
Brand name: Hizentra
Generic name: immune globulin subcutaneous (human)
Dosage form: Liquid
Company: CSL Behring
Treatment for: Primary Immunodeficiency Syndrome, Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Hizentra (immune globulin subcutaneous (human)) is an immune globulin indicated for the treatment of primary immunodeficiency, and for the maintenance treatment of chronic inflammatory demyelinating polyneuropathy.

Development timeline for Hizentra

Apr 18, 2023Approval CSL Behring Receives FDA Approval for Hizentra (Immune Globulin Subcutaneous [Human] 20% Liquid) 50mL Prefilled Syringe
Mar 16, 2018Approval FDA Approves Hizentra (Immune Globulin Subcutaneous [Human] 20% Liquid) for the Treatment of Patients With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Mar  5, 2010Approval CSL Behring Receives FDA Approval of Hizentra, First 20 Percent Subcutaneous Immunoglobulin Therapy

Further information

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