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Synribo Approval History

  • FDA approved: Yes (First approved October 26th, 2012)
  • Brand name: Synribo
  • Generic name: omacetaxine mepesuccinate
  • Company: Teva Pharmaceuticals
  • Treatment for: Chronic Myelogenous Leukemia

Synribo (omacetaxine mepesuccinate) is a first-in-class small molecule drug for the treatment of adult patients with chronic or accelerated phase chronic myeloid leukemia.

Development History and FDA Approval Process for Synribo

Oct 26, 2012Approval FDA Approves Synribo for Chronic Myelogenous Leukemia
Jan  6, 2011ChemGenex Announces alignment of European and US regulatory strategies for omacetaxine
Oct  5, 2010ChemGenex Completes pre-NDA Meeting with U.S. FDA and Clarifies Timing for Second New Drug Application for Omapro
Jul 16, 2010ChemGenex and U.S. FDA Agree on Potential Regulatory Pathway for Omapro
Apr 12, 2010ChemGenex Receives a Complete Response Letter from the FDA for Omapro
Mar 24, 2010U.S. Food and Drug Administration's Oncologic Drug Advisory Committee Recommends ChemGenex Validate a Diagnostic Prior to Approval of Omapro in Chronic Myeloid Leukemia Patients with T315I Mutation
Mar  2, 2010U.S. Food and Drug Administration (FDA) Sets 22 March for Oncologic Drugs Advisory Committee (ODAC) Meeting to Review Omapro
Feb  9, 2010Extreme Weather in Washington D.C. has Postponed the FDA's Oncologic Drugs Advisory Committee Meeting Scheduled for 10 February 2010
Dec 17, 2009ChemGenex Pharmaceuticals Announces Omapro to be Reviewed by the FDA's Oncologic Drugs Advisory Committee for the Treatment of Adults with Chronic Myeloid Leukemia who have Failed Prior Therapy with Imatinib and have the Bcr-Abl T315I Mutation
Nov 10, 2009ChemGenex Announces FDA Accepts NDA for Omapro (Omacetaxine Mepesuccinate) and Grants the Filing Priority Review Status
Sep  9, 2009ChemGenex Submits New Drug Application for Omapro (omacetaxine Mepesuccinate) to U.S. FDA
Jul  1, 2008ChemGenex Announces Submission of Non-Clinical Section of Rolling NDA for Omacetaxine
Apr 14, 2008ChemGenex appoints VP Regulatory Affairs - Confirms Planned NDA Rolling Submission for Omacetaxine Following Meeting with U.S. FDA

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