Drug Approval Package

YERVOY (ipilimumab) Injection
Company:  Bristol-Myers Squibb Company
Application No.:  125377
Approval Date: 3/25/2011

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• Approval Letter(s) (PDF)
• Officer/Employee List (PDF)
• Office Director Memo (PDF)
• Risk Evaluation and Mitigation Strategy(REMS) (PDF)
• Printed Labeling (PDF)
• Medical Review(s) (PDF)
• Chemistry Review(s) (PDF)
• Pharmacology Review(s) (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)
• Other Review(s) (PDF)
• Administrative Document(s) & Correspondence (PDF)

Date created: May 16, 2011

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