Food and Drug Administration
The committee will discuss new drug application (NDA) 21-824, proposed trade name ZARNESTRA (tipifarnib) Film Coated Tablets, Tibotec Therapeutics, a Division of Ortho Biotech, L.P., proposed indication for the treatment of elderly patients with newly diagnosed poor-risk acute myeloid leukemia.
Briefing Information
Tibotec Therapeutics, a Division
of Ortho Biotech, L.P.
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.
ZARNESTRA®
(tipifarnib) Briefing Document
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.