FDA asks Lilly to submit REMS on olanzapine LAI in complete response letter

US drug major Eli Lilly has received a complete response letter from the Food and Drug Administration for olanzapine long-acting injection  for acute and maintenance treatment of schizophrenia in adults. The FDA  does not require any additional clinical trials for the continued review  of the NDA but, as requested, Lilly is preparing a proposed Risk  Evaluation and Mitigation Strategy, which will be submitted in the near  future. "We cannot speculate on the timing of a potential decision,"  said Todd Durell, associate medical director of Lilly's US neuroscience  arm. The drug has been approved for use in the European Union and New  Zealand as Zypadhera. Other reviews are ongoing elsewhere.