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Drug Approval Package: Aduhelm (aducanumab-avwa)

Company: Biogen, Inc.
Application Number: 761178
Approval Date: 06/07/2021

Drugs@FDA information available about Aduhelm (aducanumab-avwa)

Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance.

FDA Approval Letter and Labeling

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

FDA Application Review Files

Office of Neurology's Summary Review Memorandum (PDF)
Concurrence Memorandum from Peter Stein, MD, Director, Office of New Drugs (PDF)
Memorandum from Patrizia Cavazzoni, MD, Director, Center for Drug Evaluation and Research (CDER) (PDF)
Clinical Pharmacology Review (PDF)
Medical Review (PDF)
Statistical Review (PDF)
Product Quality 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)
Administrative and Correspondence Documents (PDF)

Date created: June 22, 2021
Last updated: June 28, 2021

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