The FDA’s Neutroval CRL is for the reduction in the duration of severe neutropenia and the incidence of febrile neutropenia in patients treated with established myelosuppressive chemotherapy for cancer.
Teva said that the CRL is related to the Neutroval application requested several items which it is reviewing and will work with the FDA to determine the appropriate next steps regarding this application.
Additionally, Teva said that they have not asked by the FDA for additional pre-marketing clinical trials to complete the review of the BLA.