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Food and Drug Administration

Cardiovascular and Renal Drugs Advisory Committee

 

December 11, 2007

 

 BRIEFING INFORMATION

 

Sponsor: Astellas Pharma US, Inc.

 

Disclaimer

The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document

 

Astellas Pharma US, Inc. Briefing Material for (pdf)

NDA 22-034 (Vernakalant hydrochloride for injection)

 

FDA

 

Disclaimer

Portions of this document have been determined to be exempt from disclosure under the Freedom of Information Act (the FOIA) (5 U.S.C. §552). These redacted portions will appear as white space on the screen or on the printed page.

 

FDA Briefing Material for NDA 22-034 (pdf)

Vernakalant hydrochloride for injection

FDA Backgrounder Errata (pdf)

Page last updated December 7, 2007 kkhorizonal rule
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