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Sep 03, 2012
 |  BC Week In Review  |  Clinical News  |  Regulatory

TevaGrastim filgrastim regulatory update

FDA approved a BLA from Teva for tbo-filgrastim (XM02) to treat severe neutropenia in patients with non-myelogenous malignancies receiving chemotherapy. The human granulocyte colony-stimulating factor (G-CSF) was approved under section 351(a) of the Public Health Service Act and therefore is not considered a biosimilar of Neupogen filgrastim, a granulocyte-colony stimulating factor (G-CSF)...

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