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Firazyr Approval History

  • FDA approved: Yes (First approved August 25th, 2011)
  • Brand name: Firazyr
  • Generic name: icatibant
  • Dosage form: Injection
  • Company: Shire plc
  • Treatment for: Angioedema

Firazyr (icatibant) is a selective B2 bradykinin receptor antagonist indicated for the treatment of acute attacks of hereditary angioedema.

Development History and FDA Approval Process for Firazyr

DateArticle
Aug 25, 2011Approval FDA Approves Shire's Firazyr (icatibant injection) for Acute Attacks of Hereditary Angioedema (HAE)
Mar 21, 2011FDA Assigns PDUFA Date for Shire's Firazyr (icatibant) for the Treatment of Acute Attacks of Hereditary Angioedema
Feb 28, 2011Shire Files Complete Response to FDA's Not Approvable Letter for Firazyr (icatibant) for the Treatment of Acute Attacks of Hereditary Angioedema
Jun 23, 2008Jerini to Submit Complete Response to the FDA for Icatibant in theTreatment of HAE
Apr 24, 2008FDA Issues Not Approvable Letter for Icatibant in the Treatment ofHAE
Jan  8, 2008FDA Cancels Advisory Committee Meeting for Icatibant in the Treatment of HAE - Priority Review of Jerini's NDA Continues
Dec 21, 2007Jerini Receives NDA Filing Acceptance and Priority Review from theFDA for Icatibant in the Treatment of HAE
Oct 31, 2007Jerini Submits New Drug Application for Icatibant in the Treatment of HAE to the FDA and Requests Priority Review
Oct  8, 2007Jerini Initiates FDA Submission Process of New Drug Application for Icatibant in the Treatment of HAE

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