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Haegarda Approval History

FDA Approved: Yes (First approved June 22, 2017)
Brand name: Haegarda
Generic name: C1 esterase inhibitor (human)
Dosage form: Subcutaneous Injection
Previous Name: CSL830
Company: CSL Behring
Treatment for: Hereditary Angioedema

Haegarda (C1 esterase inhibitor (human)) is a low-volume subcutaneous (SC) C1-esterase inhibitor (C1-INH) replacement therapy to prevent Hereditary Angioedema (HAE) attacks.

Development History and FDA Approval Process for Haegarda

DateArticle
Jun 23, 2017Approval FDA Approves Haegarda - First Subcutaneous C1 Esterase Inhibitor for Hereditary Angioedema
Mar 22, 2017New England Journal of Medicine Publishes Pivotal Phase III Data for CSL Behring’s Subcutaneous C1-Esterase Inhibitor CSL830 in HAE Patients
Aug 30, 2016FDA Accepts CSL Behring's BLA for First Subcutaneous Prophylactic Therapy CSL830 to Prevent Hereditary Angioedema Attacks

Further information

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