U.S. Food and Drug Administration
Teva Provides Update on Status of Neutroval(TM) G-CSF Biologics License Application Submitted to the U.S. Food and Drug Administration
Published in Women's Health Weekly, October 14th, 2010
Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) announced 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...
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