Zarnestra Approval Status
- FDA approved: No
- Brand name: Zarnestra
- Generic name: tipifarnib
- Previous name: R115777
- Company: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Treatment for: Acute Myeloid Leukemia
Zarnestra (tipifarnib) is a farnesyltransferase inhibitor under investigation for the treatment of acute myeloid leukemia. In June 2005, the FDA issued a Not Approvable Letter for Zarnestra.
Development Status and FDA Approval Process for Zarnestra
|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|
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