FDA issues Complete Response Letter for Teva's Neutroval BLA

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.

The Complete Response Letter related to the Neutroval application requested several items which Teva is reviewing and will work with the FDA to determine the appropriate next steps regarding this application. This letter does not require additional pre-marketing clinical trials to complete the review of the BLA.