Drug Approval Package
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Krystexxa (Pegloticase) Injection
Company: Savient Pharmaceuticals, Inc.
Application No.: 125293s000
Approval Date: 9/14/2010
Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance.
- Approval Letter(s) (PDF)
- Summary Review (PDF)
- Officer/Employee List (PDF)
- Office Director Memo (PDF)
- Cross Discipline Team Leader Review (PDF)
- Risk Evaluation and Mitigation Strategy(REMS) (PDF)
- Printed Labeling (PDF)
- Medical Review(s) (PDF)
- Chemistry Review(s) (PDF)
- Enviornmental Assessment(s) (PDF)
- Immunogenicity Review (PDF)
- Pharmacology Review(s) (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 Action Letter(s) (PDF)
- Other Review(s) (PDF)
- Administrative Document(s) & Correspondence (PDF)
Date created: November 12, 2010
Vision impaired people having problems accessing certain pages of a PDF file may call (301) 796-3634 for assistance.
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