Drug Approval Package: Tegsedi (inotersen)

Company: Ionis Pharmaceuticals, Inc.
Application Number: 211172
Approval Date: 10/05/2018

Drugs@FDA information available about Tegsedi

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FDA Approval Letter and Labeling

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

FDA Application Review Files

• REMS (PDF)
• Summary Review (PDF)
• Officer/Employee List (PDF)
• Medical Review(s) (PDF)
• Chemistry Review(s) (PDF)
• Pharmacology Review(s) (PDF)
• Statistical Review(s) (PDF)
• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
• Risk Assessment and Risk Mitigation Review(s) (PDF)
• Proprietary Name Review(s) (PDF)
• Other Review(s) (PDF)

Date created: November 1, 2018

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