Exclusive: Eli Lilly supplied schizophrenia drug to uncertified healthcare providers, Form 483 shows
Eli Lilly shipped its schizophrenia drug to uncertified pharmacies and was not adhering to established safety procedures, the FDA found after a September inspection at the company’s corporate offices in Indiana.
The agency noted five deficiencies involving Zyprexa Relprevv, in which the company did not follow the approved Risk Evaluation and Mitigation Strategy (REMS), a program for drugs with serious safety concerns, according to a Form 483 obtained by Endpoints News through a FOIA request.
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.