Drug Approval Package

Vasovist (Gadofosveset Trisodium) Injection
Company: Epix Pharmaceuticals
Application No.:  021711
Approval Date: 12/22/2008

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• Approval Letter(s) (PDF)

• Approvable Letter (PDF)

• Summary Review (PDF)

• Officer/Employee List (PDF)

• Office Director Memo (PDF)

• Printed Labeling (PDF)

• Medical Review(s)

  • Part 1 (PDF)
  • Part 2 (PDF)
  • Part 3 (PDF)
• Chemistry Review(s) (PDF)

• Pharmacology Review(s)

  • Part 1 (PDF)
  • Part 2 (PDF)
  • Part 3 (PDF)

• Statistical Review(s) (PDF)

• Microbiology 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)

• Administrative Document(s) & Correspondence (PDF)

Date created: March 31, 2009

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