The U.S. Food and Drug Administration or FDA has approved Teva Pharmaceutical Industries Ltd.'s (TEVA) SYNRIBO for injection, for subcutaneous use, to include home administration, and also approved a related Medication Guide and Instructions for Use. As a result this approval, physicians who treat adults with chronic or accelerated phase CML who are no longer responding to, or who could not tolerate, two or more tyrosine kinase inhibitors or TKIs will now have the option to allow their patients to administer SYNRIBO therapy at home.
The company is in the process of finalizing a comprehensive specialty pharmacy support program, that will help facilitate successful home administration of SYNRIBO for HCPs, their patients and caregivers. This program is likely to "go live" as early as possible in the second quarter of 2014.
SYNRIBO for Injection, for subcutaneous use, is indicated to treat adult patients with chronic or accelerated phase chronic myeloid leukemia or CML with resistance and/or intolerance to two or more TKI. CML, also called chronic myelogenous leukemia, is one of four main types of leukemia and is a cancer of the blood and bone marrow.
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