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Berinert FDA Approval History

Last updated by Judith Stewart, BPharm on Feb 25, 2021.

FDA Approved: Yes (First approved October 9, 2009)
Brand name: Berinert
Generic name: C1 esterase inhibitor (human)
Dosage form: Injection
Company: CSL Behring
Treatment for: Hereditary Angioedema

Berinert (C1-esterase inhibitor (human)) is a plasma derived C1 esterase inhibitor indicated for the treatment of acute abdominal, facial, or laryngeal attacks of hereditary angioedema (HAE) in adult and pediatric patients.

Development timeline for Berinert

Jan  3, 2012Approval CSL Behring Receives FDA Approval of Expanded Label on Berinert for Self-administration and Treatment of Acute Laryngeal Attacks of Hereditary Angioedema
Oct 12, 2009Approval CSL Behring Announces FDA Approval of Berinert, First and Only Therapy Approved for the Treatment of Acute Abdominal and Facial Attacks of Hereditary Angioedema in U.S.
Mar  6, 2008CSL Behring Submits BLA Requesting Approval of C1-Esterase Inhibitor for the Treatment of Hereditary Angioedema

Further information

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