Briefing Information for the September 1, 2009 Meeting of the Oncologic Drugs Advisory Committee

 

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Morning Session

 

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).

 

FDA Briefing Material (pdf)

 

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GENZYME CORPORATION

 

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.

 

CLOLAR® (clofarabine) Injection for intravenous use, proposed indication for the treatment of previously untreated adults aged 60 years or older with acute myeloid leukemia with at least one unfavorable baseline prognostic factor 

(pdf)

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Afternoon Session

 

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).

 

FDA Briefing Material (pdf)

Errata (pdf)

 

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VION PHARMACEUTICALS, 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.

ONRIGIN® (laromustine) Injection, proposed indication for remission induction therapy for patients 60 years or older with de novopoor-risk acute myeloid leukemia (AML) (pdf)