FDA expands approval for Synribo for CML-Teva
The FDA has approved Synribo (omacetaxine mepesuccinate), from Teva, for injection, for subcutaneous use, to include home administration, and also approved a related Medication Guide and Instructions for Use, for adults with chronic or accelerated phase CML.
With 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 (TKIs) will now have the option to allow their patients to administer Synribo therapy at home. This program is expected to �go live� as early as possible in the second quarter of 2014.
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