U.S. Food and Drug Administration Approval Summary: Omacetaxine Mepesuccinate as Treatment for Chronic Myeloid Leukemia

On October 26, 2012, the U.S. Food and Drug Administration (FDA) granted accelerated approval to omacetaxine mepesuccinate (Synribo; Teva Pharmaceuticals USA, Inc., North Wales, PA, http://www.tevausa.com) for the treatment of adult patients with chronic phase (CP) or accelerated phase (AP) chronic...

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Autores principales: Alvandi, Firoozeh, Kwitkowski, Virginia E., Ko, Chia-Wen, Rothmann, Mark D., Ricci, Stacey, Saber, Haleh, Ghosh, Debasis, Brown, Janice, Pfeiler, Erika, Chikhale, Elsbeth, Grillo, Joseph, Bullock, Julie, Kane, Robert, Kaminskas, Edvardas, Farrell, Ann T., Pazdur, Richard
Formato: Artigo
Lenguaje:Inglês
Publicado: AlphaMed Press 2014
Materias:
Regulatory Issues: FDA
Acceso en línea:https://ncbi.nlm.nih.gov/pmc/articles/PMC3903068/
https://ncbi.nlm.nih.gov/pubmed/24309980
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1634/theoncologist.2013-0077
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