INDIANAPOLIS (AP) — Eli Lilly & Co. said Wednesday the Food and Drug Administration is withholding approval on the long-acting version of schizophrenia treatment olanzapine. The FDA is not requiring additional studies and the company said it is preparing a risk evaluation and mitigation strategy, to be submitted in the near future. “We cannot speculate on the timing of a potential decision, but remain confident that, if approved, the long-acting depot formulation of olanzapine will offer an important option for treating this devastating and chronic illness,” said Dr. Todd Durell, associate medical director for U.S. neuroscience at Eli Lilly. The long-acting version of olanzapine is already approved in the European Union and New Zealand under the name Zypadhera.
