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FDA wants a REMS for extended-release Zyprexa

Executive Summary

FDA will not approve Eli Lilly's long-acting version of its antipsychotic Zyprexa (olanzapine) without a Risk Evaluation and Mitigation Strategy, the agency says in a complete response letter. The depot version of the drug, which would be indicated for acute and maintenance treatment of schizophrenia in adults, has recently been approved in the EU and New Zealand. Although developing the REMS will not require a clinical trial, FDA's decision is another delay for the product. The agency had previously rejected the line extension, which had been using the tradename Zyprexa Adhera,in February 2008, saying it needed more information on the post-injection delirium and sedation observed in a small percentage of patients. Zyprexa, Lilly's top seller, loses patent protection in 2011

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