Teva gets FDA green light for second long-acting schizophrenia drug
Weltruza follows the 2023 approval of Uzedy, extending Teva's partnership with France's Medincell as it seeks to build new sources of branded drug revenue.
Teva has received U.S. Food and Drug Administration approval for Weltruza, a once-monthly injection for adults with schizophrenia, adding another product to the Israeli pharmaceutical company's growing portfolio of branded medicines as it seeks to reduce its reliance on generic drugs.
Teva said on Friday that it expects to launch Weltruza in the United States in the coming weeks. The drug is the second product approved in the U.S. to emerge from Teva's partnership with French biotechnology company Medincell, following Uzedy, a long-acting injectable form of the antipsychotic drug risperidone that received FDA approval in 2023.
Weltruza uses Medincell's long-acting injectable technology, which is designed to release medication over an extended period. The drug contains olanzapine, an antipsychotic used to treat schizophrenia. Its monthly dosing schedule could help address a longstanding challenge in treating the condition: patients' difficulty adhering to medication regimens over time.
The approval also creates a potential new source of revenue for Medincell. Under its agreement with Teva, the French company could receive up to $112 million in additional development and commercial milestone payments, as well as royalties on sales.
The deal builds on the commercial relationship established by Uzedy, which has become one of Teva's growing branded products. In the second quarter of 2026, Uzedy generated $77 million in revenue, up 43% from a year earlier, according to Teva's latest reported results. The company's portfolio of innovative medicines generated more than $1 billion in quarterly revenue for the first time during the period, an increase of 43% year over year.
Teva's existing growth drivers include Austedo, a treatment for movement disorders, and Ajovy, a migraine drug, alongside Uzedy. In the second quarter, Austedo generated $696 million in revenue, up 40% from a year earlier, while Ajovy sales rose 56% to $244 million. Teva raised its combined annual revenue forecast for the three products to $3.7 billion.
The company is also developing a broader schizophrenia treatment offering based on Uzedy and olanzapine. CTech reported in September that Teva sees the combination as having the potential to generate peak annual revenue of $2 billion. Weltruza's approval provides another step toward expanding the company's presence in the market, although its eventual commercial contribution will depend on uptake following launch.
