Teva and Medincell Receive FDA NDA Acceptance for Olanzapine Long-Acting Injectable

The U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for an investigational long-acting injectable (LAI) formulation of olanzapine developed by Teva Pharmaceutical Industries (NYSE: TEVA) and partner Medincell. The submission seeks approval for the treatment of schizophrenia in adults. The candidate utilizes Medincell’s proprietary BEPO technology to provide sustained release of the medication, aiming to address adherence challenges associated with daily oral antipsychotics. This regulatory milestone advances Teva’s "Pivot to Growth" strategy, specifically its focus on expanding the neuroscience portfolio. The FDA is expected to set a Prescription Drug User Fee Act (PDUFA) target action date within the standard review period.