Food and Drug Administration

Oncologic Drug Advisory Committee

December 1, 2004

Briefing Information


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.

Clofarabine Briefing Document, NDA 21-673, Vol. I, Ilex Products (PDF)

Clofarabine Briefing Document, NDA 21-673, Vol. II, Ilex Products (PDF)

Clinical Review, Clofarabine Briefing Document, FDA (HTM) (PDF) (Word)

Marqibo® (Vincristine Sulfate Liposomes Injection), Inex Pharmaceuticals Corp. (co-developed with Enzon Pharmaceuticals Inc.) (PDF)

Marqibo® (Vincristine Sulfate Liposomes Injection), FDA Review (PDF)

FDA Briefing Document Errata Sheet (HTM) (PDF) (Word)