Teva gains full FDA approval of CML drug Synribo

Israel-based Teva Pharmaceutical Industries (NYSE: TEVA) says the US Food and Drug Administration has granted full approval of leukemia drug Synribo (omacetaxine mepesuccinate) for injection, to treat adults with chronic myelogenous leukemia (CML), a blood and bone marrow disease.

This oncology portfolio product received an accelerated approval in October 2012 with additional clinical trial data required to fulfil post-marketing requirements set out by the FDA (The pharma Letter October 29, 2012).

Teva, best known as the world’s largest generic drugmaker, acquired rights to the drug along with its $6.8 billion acquisition of US biotech firm Cephalon, which itself had purchased omacetaxine’s originator, Australia-based ChemGenex.