FDA approves Teva's Granix Injection for self-administration

JERUSALEM — Teva Pharmaceutical today announced that the Food and Drug Administration has approved Granix (tbo-filgrastim) Injection for self-administration by patients and caregivers. With the approval of this additional administration option, physicians will soon have the flexibility to prescribe Granix for either in-office or at home use.



Granix, a leukocyte growth factor, is indicated for reduction in the duration of severe neutropenia in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia.



Granix has been commercially available in the United States since November 2013. The currently marketed Granix syringe is indicated only for administration by a healthcare professional. Teva plans to launch a new Granix syringe, for self-administration by patients and caregivers, in early 2015.