Medincell and Teva Submit FDA Application for New Injectable Treatment

Teva Pharmaceuticals, in partnership with Medincell, has submitted a New Drug Application to the U.S. FDA for olanzapine extended-release injectable suspension (TEV-749/mdc-TJK). This medication is intended for the once-monthly treatment of schizophrenia in adults. The olanzapine long-acting injectable aims to provide efficacy comparable to regular olanzapine, while enhancing patient adherence and stability.

The FDA review typically spans two months for acceptance and a further eight months for a standard review. Olanzapine LAI is designed to bridge a critical treatment gap, addressing adherence issues common in schizophrenia management. Medincell's partnership with Teva is part of their broader strategy to develop long-acting injectables for various therapeutic areas.