Drug Approval Package

Victoza (Liraglutide [rDNA]) Injection
Company:  Novo Nordisk Inc.
Application No.:  022341
Approval Date: 1/25/2010

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• Approval Letter(s) (PDF)
• Summary Review (PDF)
• Risk Evaluation and Mitigation Strategy (REMS) (PDF)
• Officer/Employee List (PDF)
• Cross Discipline Team Leader Review (PDF)
• Printed Labeling (PDF)
• Medical Review(s)
  • Part 1 (PDF)
  • Part 2 (PDF)
• Chemistry Review(s) (PDF)
• Pharmacology Review(s)
  • Part 1 (PDF)
  • Part 2 (PDF)
  • Part 3 (PDF)
• Statistical Review(s) (PDF)
• Microbiology Review(s) (PDF)
• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
• Risk Assessment and Risk Mitigation Review(s) (PDF)
• Proprietary Name Review(s) (PDF)
• Administrative Document(s) & Correspondence (PDF)

Date created: April 20, 2010

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