The U.S. Food and Drug Administration (FDA) has granted Israeli-based Teva Pharmaceuticals full approval for Synribo, a drug that is injected for adults with a with chronic phase or accelerated phase of myeloid leukemia.
Chronic myeloid leukemia, also known as chronic myelogenous leukemia, is one of four main types of leukemia and is a cancer of the blood and bone marrow.
The FDA had given initial approval for the drug in October 2012 but said Teva had to provide additional clinical trial data before it could bring the drug to market.
“With this approval, based on the final analysis of two Phase II trials that evaluated efficacy and tolerability data of Synribo, we believe healthcare providers can be even more confident in the clinical profile of this important medicine, said Teva president and CEO global specialty medicines Rob Koremans.