Drug Approval Package: Onpattro (patisiran)
Company: Alnylam Pharmaceuticals, Inc.
Application Number: 210922
Approval Date: 08/10/2018
Application Number: 210922
Approval Date: 08/10/2018
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
Date created: September 7, 2018
Vision impaired people having problems accessing certain pages of a PDF file may call (301) 796-3634 for assistance.
Note: Documents in PDF format require the Adobe Acrobat Reader®.