FDA requires a REMS for Lilly's long-acting olanzapine
This article was originally published in Scrip
Executive Summary
The US FDAhas issued Lillywith a complete response letter for its olanzapine long-acting injection (LAI) – a once-monthly treatment for the acute and maintenance therapy of schizophrenia in adults, which is a long-acting version of its antipsychotic Zyprexa (olanzapine).