Breaking News, Trials & Filings

Lilly’s Zyprexa LAI Gets Non-approvable Letter

Author Image

By: Tim Wright

Editor-in-Chief, Contract Pharma

Eli Lilly and Co. received a not approvable letter from the FDA for Zyprexa long-acting injection (olanzapine LAI) for the treatment and maintenance of schizophrenia in adults. Zyprexa LAI is an investigational formulation that combines the antipsychotic medication Zyprexa (olanzapine) with a pamoate salt, for an extended delivery of up to four weeks.     In its letter, the FDA said it needs more information to better understand the risk and underlying cause of excessive sedation events that ...

Continue reading this story and get 24/7 access to Contract Pharma for FREE


Already a subscriber? Sign in

Keep Up With Our Content. Subscribe To Contract Pharma Newsletters