- For routine prophylaxis against angioedema attacks in adolescent and adult patients with Hereditary Angioedema (HAE).
- February 11, 2014 Approval Letter - CINRYZE
To include revisions to the Warnings and Precautions section of the package insert to include the risk factors for thromboembolic events.
January 3, 2012 Summary Basis for Regulatory Action - Cinryze(PDF - 153KB) January 9, 2012 Approval Letter-CINRYZE
To include the incorporation of additional safety data from the open-label uncontrolled routine prophylaxis trial protocol LEVP2006-4 (“Change 3” study) into the labeling.
October 10, 2008 Approval Letter - CINRYZE
Product is intended for routine prophylaxis against angioedema attacks in patients with Hereditary Angioedema (HAE).
Summary Basis for Regulatory Action - CINRYZE Approval History, Letters, Reviews and Related Documents - CINRYZE[ARCHIVED]
FDA Online Label Repository
Search this database for drug labeling and other information. The content has not been altered or verified by the FDA and may not be the labeling on currently distributed products or identical to the labeling that is approved.
FDA Licenses for Marketing New Therapy for Rare Genetic Disease[ARCHIVED]
Press Release, 10/10/2008