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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)