Firazyr
Generic name: icatibant
Treatment for: Angioedema
FDA Issues Not Approvable Letter for Icatibant
FDA Issues Not Approvable Letter for Icatibant in the Treatment ofHAE
BERLIN, Germany, April 24, 2008 - Jerini AG has received a not approvable letter from the FDA for its New Drug Application (NDA) for Icatibant in the treatment of hereditary angioedema (HAE). The not approvable letter outlines areas of concern that the company is now going to review with the agency. Jerini is expecting an opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) for Icatibant in the treatment of HAE later today.
ISIN: DE0006787476 Regulated Market / Prime Standard; Frankfurt Stock Exchange, Germany
Posted: April 2008
Related articles
- FDA Approves Shire's Firazyr (icatibant injection) for Acute Attacks of Hereditary Angioedema (HAE) - August 25, 2011
- FDA Assigns PDUFA Date for Shire's Firazyr (icatibant) for the Treatment of Acute Attacks of Hereditary Angioedema - March 21, 2011
- Shire Files Complete Response to FDA's Not Approvable Letter for Firazyr (icatibant) for the Treatment of Acute Attacks of Hereditary Angioedema - February 28, 2011
- Jerini to Submit Complete Response to the FDA for Icatibant in theTreatment of HAE - June 23, 2008
- FDA Cancels Advisory Committee Meeting for Icatibant in the Treatment of HAE - Priority Review of Jerini's NDA Continues - January 8, 2008
- Jerini Receives NDA Filing Acceptance and Priority Review from theFDA for Icatibant in the Treatment of HAE - December 21, 2007
- Jerini Submits New Drug Application for Icatibant in the Treatment of HAE to the FDA and Requests Priority Review - October 31, 2007
- Jerini Initiates FDA Submission Process of New Drug Application for Icatibant in the Treatment of HAE - October 8, 2007
Firazyr (icatibant) FDA Approval History
More news resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Drug Shortages
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.