Drug Approval Package

 Prialt (Ziconotide Intrathecal Infusion)
Company:  Elan Pharmaceuticals
Application No.:  021060
Approval Date: 12/28/2004

• Approval Letter(s) (PDF)

• Printed Labeling (PDF)

• Medical Review(s) (PDF)  

• Chemistry Review(s) (PDF)

• Pharmacology Review(s) (PDF)

• Statistical Review(s) (PDF)

• Microbiology Review(s) (PDF)  

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)

• Administrative Document(s) & Correspondence (PDF)  

Date created: April 222005

Back to Top    Drugs@FDA

Note: Documents in PDF format require the Adobe Acrobat Reader®.