PharmiWeb

Medincell: U.S. Food and Drug Administration (FDA) Accepts Teva’s New Drug Application (NDA) for Olanzapine Extended-Release Injectable Suspension (TEV-'749) for the Once ...

Olanzapine long-acting injectable suspension (TEV-'749) has the potential to offer the efficacy of olanzapine in a once-monthly, subcutaneous formulation 1If approved, TEV-'749 could help address a ...
Drug Store News

FDA issues not-approvable letter to Eli Lilly for Zyprexa injection

INDIANAPOLIS Eli Lilly reported the receipt of a not-approvable letter on Thursday from the Food and Drug Administration for Zyprexa long-acting injection for the treatment and maintenance treatment ...
The Pharma Letter

BRIEF—Teva announces FDA filing acceptance for olanzapine NDA

Israel-based generics giant Teva Industries and France’s Medincell announced that the US Food and Drug Administration has accepted the New Drug Application for olanzapine extended-release injectable ...
FierceBiotech

FDA Advisory Committee Supports Efficacy and Safety of Zyprexa(R) Long-Acting Injection (LAI) for Schizophrenia Treatment

In clinical trials, Zyprexa LAI had a safety profile similar to oral olanzapine, with the exception of post- injection excessive sedation events, which also include dizziness, confusion and altered ...
Washington Examiner

FDA investigates Zyprexa Relprevv patient deaths

Federal regulators are investigating the deaths of two patients who received injections of a longer-lasting version of Eli Lilly’s antipsychotic Zyprexa. The Food and Drug Administration said Tuesday ...