Drug Approval Package: Praluent (alirocumab)
Company: Sanofi-Aventis U.S. Inc.
Application Number: 125559
Approval Date: 08/22/2018
Application Number: 125559
Approval Date: 08/22/2018
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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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