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Food and
Drug Administration
Endocrinologic
and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management
Advisory Committee
July 30,
2007
BRIEFING INFORMATION
Cardiovascular
ischemic/thrombotic risks of the thiazolidinediones, with focus on
rosiglitazone, as presented by FDA and GlaxoSmithKline.
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.
GlaxoSmithKline
Briefing Document (pdf)
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 Document (pdf)