Content about Omacetaxine mepesuccinate

February 13, 2014

Teva Pharmaceutical Industries announced that the Food and Drug Administration has granted full approval of Synribo (omacetaxine mepesuccinate) for injection.

JERUSALEM — Teva Pharmaceutical Industries on Thursday announced that the Food and Drug Administration has granted full approval of Synribo (omacetaxine mepesuccinate) for injection.

The drug is indicated for adult patients with chronic phase or accelerated phase chronic myeloid leukemia with resistance and/or intolerance to two or more tyrosine kinase inhibitors.

October 26, 2012

The Food and Drug Administration has approved what it called the second new drug in two months for a form of leukemia, the agency said Friday.

SILVER SPRING, Md. — The Food and Drug Administration has approved what it called the second new drug in two months for a form of leukemia, the agency said Friday.

The FDA announced the approval of Teva Pharmaceutical Industries' Synribo (omacetaxine mepesuccinate) for chronic myelogenous leukemia, or CML, a disease that the National Institutes of Health expects will be diagnosed in more than 5,400 people this year. The drug is intended for patients whose disease has progressed after treatment with at least two drugs of a class used to treat the disease.