FDA Approves Teva’s Weltruza, First Once-Monthly Injectable Olanzapine for Schizophrenia
The FDA has approved Teva's Weltruza, the first and only once-monthly subcutaneous injectable form of olanzapine for adults with schizophrenia, with a U.S. launch expected in the coming weeks.
The U.S. Food and Drug Administration has approved Weltruza, Teva’s extended-release injectable form of olanzapine, for adults with schizophrenia, the company said on Friday, according to Reuters.
The approval makes Weltruza the first and only once-monthly subcutaneous injectable olanzapine available for this patient group, according to the company. The treatment is given as an extended-release injectable suspension.
Launch expected in the coming weeks
Israel-based Teva is leading the development and commercialization of the treatment under its partnership with France’s Medincell, and said it expects to launch the product in the United States in the coming weeks, according to Reuters.
The once-monthly dosing schedule is intended to give adults living with schizophrenia a long-acting treatment option that does not require daily dosing.
Reporting based on coverage by Reuters.
