Teva Secures FDA Clearance for Weltruza, Monthly Schizophrenia Injection

Teva reported that the U.S. Food and Drug Administration has granted approval for Weltruza, a monthly injectable treatment for adults with schizophrenia. This marks the second U.S.-approved product from the collaboration between Israel’s Teva and France’s Medincell, the first being Uzedy, a long-acting risperidone injection cleared in 2023. Weltruza leverages Medincell’s proprietary technology that sustains drug release over an extended period, addressing common adherence challenges in chronic mental-health conditions.

The company said it will introduce the medication in the United States in the coming weeks. Under their partnership, Medincell could receive up to $112 million in additional development and commercial milestones, plus ongoing sales royalties. Market reaction was positive, with Teva shares gaining 2 percent on the Tel Aviv exchange and Medincell shares climbing 16.9 percent in Paris.