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FDA Issues Complete Response Letter on Olanzapine Long-Acting Injection
The FDA does not require any additional clinical trials for the continued review of the NDA. Per the agency's request, Lilly is preparing a proposed Risk Evaluation and Mitigation Strategy (REMS), which will 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 Todd Durell, M.D., associate medical director for U.S. neuroscience for Lilly.
This treatment has been approved for use in the European Union and New Zealand under the trade name Zypadhera(TM). Independent regulatory reviews are ongoing in other countries.
Source: Eli Lilly and Company