Drug Approval Package: LIBTAYO (cemiplimab-rwlc)

Company: Regeneron Pharmaceuticals, Inc.
Application Number: 761097
Approval Date: 09/28/2018

Drugs@FDA information available about LIBTAYO

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FDA Approval Letter and Labeling

• Approval Letter(s) (PDF)
• Printed Labeling (PDF)

FDA Application Review Files

• Multi-Discipline Review/Summary, Clinical, Non-Clinical (PDF)
• Officer/Employee List (PDF)
• Chemistry 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: October 30, 2018

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