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Joint meeting of the Anti-Infective Drugs Advisory Committee and the Pediatric Advisory Committee
April 12, 2007
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 or “….” on the screen or on the printed page.
FDA Briefing Document, (pdf)
The statements contained in this document(s) are those of the product's sponsors, 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.
Thallion Pharmaceuticals formerly Caprion Pharmaceuticals Inc. Briefing Material (pdf)
Teijin America, Inc. Briefing Material (pdf)