Drug Approval Package: Praluent (alirocumab)

Company: Sanofi-Aventis U.S. Inc.
Application Number: 125559
Approval Date: 08/22/2018

Drugs@FDA information available about Praluent

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FDA Approval Letter and Labeling

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

FDA Application Review Files

• Medical Review(s) (PDF)
• Statistical Review(s) (PDF)
• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
• Other Review(s) (PDF)

Date created: January 9, 2019

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