Teva Pharmaceutical Industries Limited Provides Update on Status of Neutroval(TM) (G-CSF) Biologics License Application Submitted to the U.S. FDA

JERUSALEM--(BUSINESS WIRE)--Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) announced today that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter for the Biologic License Application (BLA) for Neutroval™ (granulocyte colony-stimulating factor) for the reduction in the duration of severe neutropenia and the incidence of febrile neutropenia in patients treated with established myelosuppressive chemotherapy for cancer. The FDA issues Complete Response Letters to request additional information needed to complete the review of applications for product approval.