www.fdanews.com/articles/113593-fda-requests-rems-for-long-acting-injectable-formulation-of-zyprexa
FDA Requests REMS for Long-Acting Injectable Formulation of Zyprexa
January 9, 2009
The FDA decided again to reject a long-acting injectable formulation of Eli Lilly’s Zyprexa and asked the company to establish a risk evaluation and mitigation strategy (REMS) for the drug. The REMS is the only thing keeping the product from being approved, and no additional clinical trials are required, the company said. The surveillance program would address and quantify the drug’s risk for post-injection delirium and sedation, which can lead to comas.
Drug Industry Daily
Drug Industry Daily