Drug Approval Package

 Vivitrol (Naltrexone)
Company:  Alkermes
Application No.:  021897
Approval Date: 04/13/2006

• Approval Letter(s) (PDF)  

• Approvable Letter (PDF)
• Printed Labeling (PDF)
• Medical Review(s) (PDF)  
  Part 1 (PDF)  
  Part 2 (PDF)  
  Part 3 (PDF)  
  Part 4 (PDF)    

• Chemistry Review(s) (PDF)  

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

• Statistical Review(s) (PDF)    

• Microbiology Review(s) (PDF)     

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF) 

• Administrative Document(s) & Correspondence (PDF)

Date created: January 16, 2008

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