Drug Approval Package

Byetta (exenatide) Injection
Company: Amylin Pharmaceuticals, Inc.
Application No.: 021919
Approval Date: 10/30/2009

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• Approval Letter(s) (PDF)
• Summary Review (PDF)
• Officer/Employee List (PDF)
• Cross Discipline Team Leader Review (PDF)
• Printed Labeling (PDF)
• Medical Review(s) (PDF)
• Chemistry Review(s) (PDF)
• Pharmacology Review(s) (PDF)
• Statistical Review(s) (PDF)
• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
• Risk Evaluation and Mitigation Strategy (PDF)
• Risk Assessment and Risk Mitigation Review(s) (PDF)
• Other Action Letter(s) (PDF)
• Other Review(s) (PDF)
• Administrative and Correspondence Documents (PDF)

Date created: August 20, 2010

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