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Berinert Approval History

  • FDA approved: Yes (First approved October 9th, 2009)
  • Brand name: Berinert
  • Generic name: C1 esterase inhibitor (human)
  • Dosage form: Injection
  • Company: CSL Behring
  • Treatment for: 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 adolescent patients.

Development History and FDA Approval Process for Berinert

DateArticle
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

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