Neutroval regulatory update

FDA issued a complete response letter for a BLA from Teva for Neutroval to reduce the duration of severe neutropenia and the incidence of febrile neutropenia in patients treated with established myelosuppressive chemotherapy for cancer. Teva said the agency requested "several items" in the letter, but the company did not disclose details about the type of information requested. The company, which plans to continue to pursue the BLA regulatory pathway for Neutroval, did say the agency is not requiring any additional clinical trials. ...