FDA approves Teva’s Granix and Galderma’s Soolantra

The Food and Drug Administration has approved Israeli generics giant Teva Pharmaceutical Industries’ (NYSE: TEVA) 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, the company noted.

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 USA 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.