FDA Approvals of 2012

20 of 39


Drug: Neutroval
Generic molecule: tbo-filgrastim
Company: Sicor Biotech, subsidiary of Teva Pharmaceuticals
Approval date: Aug. 29

The scoop: Sicor Biotech's tbo-filgrastim, which will be marketed by Teva ($TEVA) as Neutroval, is intended to reduce the time certain patients receiving cancer chemotherapy experience severe neutropenia, which is a decrease in neutrophils, white blood cells that fight infection. Tbo-filgrastim is intended for use in adults taking chemotherapy drugs that lead to a decrease in the production of these cells in the bone marrow; it stimulates production of neutrophils. Upon approval, Teva touted the drug as the first new granulocyte colony-stimulating factor (G-CSF) to be approved in the U.S. in more than a decade. Teva won't begin marketing the drug until November 2013 as part of an agreement with Amgen.