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USFDA Approves Teva's Once-Monthly Schizophrenia Injection Weltruza

October 13, 2026

Original source summary

Gdansk : Teva ​said on Friday it had received approval ‌from the US Food and Drug Administration for Weltruza, a once-monthly injection for adults with ​schizophrenia. Weltruza is the second US-approved product ​from Israel-based Teva's partnership with French ⁠biotech company Medincell after Uzedy, a long-acting ​injectable form of antipsychotic drug risperidone, which ​the FDA approved in 2023. Teva , which leads the development and commercialisation of Weltruza, said it expected ​to launch the drug in the US ​in the coming weeks. The product uses Medincell's long-acting injectable ‌technology, ⁠which is designed to release medicines over extended periods. Analysts see potential for long-acting antipsychotic formulations to help address treatment-adherence challenges ​in chronic ​psychiatric illnesses, ⁠as long-acting olanzapine may in schizophrenia. Medincell may be eligible for ​up to $112 million in additional development ​and ⁠commercial milestone payments under its agreement with Teva, along with royalties on sales. Shares of ⁠Teva ​closed 2% higher in ​Tel Aviv; Medincell closed 16.9% higher in Paris Also Read: Pfizer, Teva Fail to Disqualify Former Prosecutor in US Generic Drug Price-Fixing Case

Verbatim from Medical Dialogues's own feed — "USFDA Approves Teva's Once-Monthly Schizophrenia Injection Weltruza"

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