Drug Approval Package
Vimpat (lacosamide) Injection & Tablets
Company: Schwarz Biosciences, Inc.
Application No.: 022253 & 022254
Approval Date: 10/28/2008
Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance.
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Summary Review (PDF)
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Officer/Employee List (PDF)
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Printed Labeling (PDF)
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Medical Review(s)
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Chemistry Review(s) (PDF)
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Environmental Assessment (PDF)
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Pharmacology Review(s)
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Statistical Review(s) (PDF)
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Microbiology Review(s) (PDF)
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Clinical Pharmacology Biopharmaceutics Review(s)
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Administrative Document(s) & Correspondence
Approval Letter(s) (PDF)
Date created: December 17, 2008
Note: Documents in PDF format require the Adobe Acrobat Reader®.