Synribo FDA Approval History
FDA Approved: Yes (First approved October 26, 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 timeline for Synribo
| Date | Article |
|---|
| Oct 26, 2012 | Approval FDA Approves Synribo for Chronic Myelogenous Leukemia |
| Jan 6, 2011 | ChemGenex Announces alignment of European and US regulatory strategies for omacetaxine |
| Oct 5, 2010 | ChemGenex Completes pre-NDA Meeting with U.S. FDA and Clarifies Timing for Second New Drug Application for Omapro |
| Jul 16, 2010 | ChemGenex and U.S. FDA Agree on Potential Regulatory Pathway for Omapro |
| Apr 12, 2010 | ChemGenex Receives a Complete Response Letter from the FDA for Omapro |
| Mar 24, 2010 | U.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, 2010 | U.S. Food and Drug Administration (FDA) Sets 22 March for Oncologic Drugs Advisory Committee (ODAC) Meeting to Review Omapro |
| Feb 9, 2010 | Extreme Weather in Washington D.C. has Postponed the FDA's Oncologic Drugs Advisory Committee Meeting Scheduled for 10 February 2010 |
| Dec 17, 2009 | ChemGenex 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, 2009 | ChemGenex Announces FDA Accepts NDA for Omapro (Omacetaxine Mepesuccinate) and Grants the Filing Priority Review Status |
| Sep 9, 2009 | ChemGenex Submits New Drug Application for Omapro (omacetaxine Mepesuccinate) to U.S. FDA |
| Jul 1, 2008 | ChemGenex Announces Submission of Non-Clinical Section of Rolling
NDA for Omacetaxine |
| Apr 14, 2008 | ChemGenex appoints VP Regulatory Affairs - Confirms Planned NDA Rolling Submission for Omacetaxine Following Meeting with U.S. FDA |
Further information
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