Drug Approval Package: Onpattro (patisiran)

Company: Alnylam Pharmaceuticals, Inc.
Application Number: 210922
Approval Date: 08/10/2018

Drugs@FDA information available about Onpattro

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

• 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: September 7, 2018

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