Drug Approval Package: VYEPTI

Company: Lundbeck Seattle BioPharmaceuticals, Inc.
Application Number: 761119
Approval Date: 02/21/2020

Drugs@FDA information available about VYEPTI

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FDA Approval Letter and Labeling

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

FDA Application Review Files

• Product Quality Review(s) (PDF)
• Clinical Pharmacology and Biopharmaceutics Review(s) (PDF)
• Clinical Review(s) (PDF)
• Non-Clinical Review(s) (PDF)
• Proprietary Name Review(s) (PDF)
• Officer/Employee List (PDF)
• Other Review(s) (PDF)
• Risk Assessment and Risk Mitigation Review(s) (PDF)
• Statistical Review(s) (PDF)
• Summary Review (PDF)
• Administrative and Correspondence Documents (PDF)

Date created: March 23, 2020

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