Product Approval Information
Proper Name: C1 Esterase Inhibitor (Human)
Tradename: CINRYZE
Manufacturer: Lev Pharmaceuticals, Inc.,
License #. 1780
- Package insert (PDF, 162 KB) - October 2008
Date: October 10, 2008
Indication: For routine prophylaxis against angioedema attacks in patients with Hereditary Angioedema (HAE).
October 10, 2008 Approval Letter
FDA Licenses for Marketing New Therapy for Rare Genetic Disease - 10/10/2008
Summary Basis for Regulatory Action
Approval History, Letters, Reviews, and Related Documents
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