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Haegarda FDA Approval History

Last updated by Judith Stewart, BPharm on March 8, 2021.

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 for routine prophylaxis to prevent Hereditary Angioedema (HAE) attacks in patients 6 years of age and older.

Development timeline for Haegarda

Sep 28, 2020Approval U.S. FDA Approves Haegarda (C1 Esterase Inhibitor Subcutaneous [Human]) for Prevention of Hereditary Angioedema (HAE) Attacks in Pediatric Patients (patients 6 years of age and older).
Jun 23, 2017Approval FDA Approves Haegarda - First Subcutaneous C1 Esterase Inhibitor for Hereditary Angioedema
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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