Drug Approval Package

Kuvan (Sapropterin Dihydrochloride) Tablets
Company: BioMarin Pharmaceutical, Inc.
Application No.:  022181
Approval Date: 12/13/2007

• Approval Letter(s) (PDF)  
  

• Printed Labeling (PDF)  
  
• Summary Review (PDF)  
  
• Officer/Employee List (PDF)  
  
• Cross Discipline Team Leader Review (PDF)  
  
• Medical Review(s)
  Part 1 (PDF)  
  Part 2 (PDF)  
  Part 3 (PDF)  
  

• Chemistry Review(s) (PDF)  
  

• Pharmacology Review(s) 
  Part 1 (PDF)  
  Part 2 (PDF)  
  Part 3 (PDF)  

• Statistical Review(s) (PDF)  
  

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)  

• Proprietary Name Review(s) (PDF)  

• Administrative Document(s) & Correspondence (PDF)  
  

Date created: March 24, 2008

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