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

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