Zarnestra FDA 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.

Development timeline for Zarnestra

Date	Article
Jun 30, 2005	Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Receives Not Approvable Letter From FDA for Tipifarnib Based on Phase II Data
Jan 24, 2005	Johnson & Johnson Completes Submission of Tipifarnib NDA to FDA

Further information

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