Drug Approval Package: TPOXX (tecovirimat)

Company: SIGA Technologies, Inc.
Application Number: 208627
Approval Date: 07/13/2018

Drugs@FDA information available about TPOXX

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FDA Approval Letter and Labeling

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

FDA Application Review Files

• Summary Review (PDF) (Updated)
• Officer/Employee List (PDF)
• Office Director Memo (PDF) (Updated)
• Medical Review(s) (PDF) (Updated)
• Chemistry Review(s) (PDF)
• Pharmacology Review(s) (PDF)
• Statistical Review(s) (PDF)
• Microbiology Review(s) (PDF) (Updated)
• Clinical Pharmacology Biopharmaceutics 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: August 15, 2018; updated September 12, 2022

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