Drug Approval Package

 Soliris (Eculizumab) Injectable I.V.
Company: Alexion Pharmaceuticals
Application No.: 125166
Approval Date: 03/16/2007

• Approval Letter(s) (PDF)  

• Printed Labeling (PDF)  

• Medical Review(s) (PDF)

• Chemistry Review(s) (PDF)  

• Pharmacology Review(s) (PDF)  

• Pharmacometrics Review(s) (PDF)  

• Statistical Review(s) (PDF)  

• Microbiology Review(s) (PDF)  

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)  

• Administrative Document(s) & Correspondence (PDF)  

Date created: May 17, 2007

Back to Top    Drugs@FDA

Note: Documents in PDF format require the Adobe Acrobat Reader®.