Zarnestra Approval Status

· FDA approved: No

· Brand name: Zarnestra

· Generic name: tipifarnib

· Dosage form: Oral

· Previous name: R115777

· Company: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

· Treatment for: Acute Myeloid Leukemia

Zarnestra (tipifarnib) is a farnesyltransferase inhibitor intended for use in the treatment of acute myeloid leukemia (AML) in elderly patients who are not candidates for standard chemotherapy.

In June 2005, Johnson & Johnson Pharmaceutical Research & Development, L.L.C. announced the receipt of a not approvable letter from the U.S. Food and Drug Administration (FDA) for the tipifarnib new drug application (NDA), advising the NDA could not be approved based on the submitted data.