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The once-a-month extended-release injectable suspension incorporates Medincell’s copolymer technology. Credit: PhotobyTawat/Shutterstock.com. Teva Pharmaceuticals and Medincell have gained approval from the US Food and Drug Administration (FDA) for Uzedy (risperidone), a once-a-month extended-release injectable suspension to treat adult patients with bipolar I disorder (BD-I). The medication has been approved for use as a standalone treatment or as an addition to lithium or valproate therapies for maintenance treatment of the disorder. The US regulator’s clearance for Uzedy is supported by a combination of current clinical data and model-informed drug development (MIDD) techniques. These methods capitalise on the established efficacy and safety profiles of previously approved risperidone formulations indicated for BD-I. The agency also considered Uzedy’s tolerability, efficacy and extended safety data in schizophrenia treatment, substantiated by the pivotal Phase III RISE and SHINE studies. Uzedy received FDA approval in 2023 to treat schizophrenia in adults. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence Teva US Commercial executive vice-president Chris Fox stated: “Adults living with BD-I experience debilitating manic and depressive symptoms, and today’s FDA approval of Uzedy provides a new long-acting formulation of risperidone that may help address existing unmet needs and treatment gaps. “This expanded indication for Uzedy builds on its success in adults living with schizophrenia and demonstrates Teva’s dedication to developing innovative medicines for complex mental health conditions that place a heavy burden on individuals and their caregivers.” Uzedy is a long-acting risperidone formula, incorporating Medincell’s copolymer technology, SteadyTeq, which ensures a consistent release of the medication. Therapeutic blood levels are achieved within six to 24 hours following a single administration. With the FDA’s approval, Uzedy now offers three monthly dosing options for BD-I patients: 50mg, 75mg and 100mg. In August 2025, Teva’s Ajovy received the agency’s approval for label expansion, marking it as the first migraine prevention medication for specific paediatric groups. Pharmaceutical Technology Excellence Awards - The Benefits of Entering Gain the recognition you deserve! The Pharmaceutical Technology Excellence Awards celebrate innovation, leadership, and impact. By entering, you showcase your achievements, elevate your industry profile, and position yourself among top leaders driving pharmaceutical advancements. Don’t miss your chance to stand out—submit your entry today! Nominate Now

More than 50% of Teva’s U.S. products—including its lead drug Austedo—are manufactured locally across eight production sites, the company's CFO, Eli Kalif, said Wednesday. As more drugmakers begin to report second-quarter earnings against the backdrop of the first material pharmaceutical tariff reveal from the Trump administration, Teva Pharmaceuticals isn’t sweating the situation.The Israel-based generics and innovative medicines hybrid has “absorbed the already confirmed tariffs into our 2025 guidance,” Teva’s CFO, Eli Kalif, said on a call with analysts Wednesday.More than 50% of Teva’s U.S. products—including its lead drug Austedo—are manufactured locally across eight production sites, Kalif pointed out. Further, the company has “very limited exposures” in India and China, with Kalif attributing Teva’s lack of reliance on the latter country to the closure of its API business there four years back.“All in all, when we are looking at our supply chain, our ability to actually build inventory and to manage our manufacturing steps, we don’t see here, currently, any meaningful impact for the short term,” Kalif said. The CFO’s comments came after pharmaceutical import tariffs finally surfaced in a new trade deal struck between the U.S. and the European Union (EU) on Sunday. Under the current terms of the deal, the tariff rate stands at 15% for pharmaceutical imports—and those of many other goods—entering the U.S. from Europe.Many unknowns still surround the EU tariffs, including how the U.S.’ Section 232 investigation into the national security implications of pharmaceutical imports could influence the current rate, if at all. Further, in a potentially key carveout for Teva, certain generic drugs will be excluded from the tariffs, though it’s currently unclear which ones.Teva has “done very comprehensive work to understand how we can mitigate the impact [of tariffs] on our business,” the company’s CEO, Richard Francis, said on the call. He cautioned, however, that “there’s a lot of ambiguity about what really occurred with these tariffs,” referring to the 15% duties in the U.S.-EU accord.“I think the way we’ve always played this on tariffs is to be very conservative,” Francis added. “[W]e think about this comprehensively, and probably with a more glass-half-empty approach.”Francis noted that the company has several mitigation plans prepped that Teva can roll out once more details on the Trump administration’s pharmaceutical tariffs become clear.Teva has good reason to want to keep those tariffs from impacting its business as it continues a sales growth rebound and innovative medicines pivot under a multi-year turnaround strategy dubbed “Pivot to Growth.”While Teva is continuing to make good on many different aspects of its plan, the company’s performance in the second quarter was a bit more mixed than it has been in other recent earnings periods.All told, Teva’s revenue grew 1% at constant currencies to $4.2 billion after taking sales from the company’s generics joint venture with Takeda out of the mix. Late last year, Teva and Takeda decided to divest the Japan business to better focus on their own innovative medicine ambitions.When including the Japan JV sales, Teva’s total revenue for the period was flat year over year, according to a company earnings presentation (PDF).Nevertheless, Teva’s focus on its innovative portfolio continues to pay off, with the company now raising its full-year sales guidance for all three of its key marketed meds: Austedo, Uzedy and Ajovy.Teva’s chief drug, Austedo—approved in Huntington’s disease and tardive dyskinesia—grew sales 19% to $498 million for the quarter and is now expected to bring home sales between $2 billion and $2.05 billion for the year, compared to a previous range of $1.95 billion to $2.05 billion.Ajovy for migraine prevention, which delivered second-quarter sales growth of 31% to $155 million, is now pegged to reach sales between $630 million and $640 million, versus a prior projection of roughly $600 million.And Teva’s long-acting risperidone product for schizophrenia, Uzedy, is now in the running to secure $190 million to $200 million in 2025 sales after growing 120% in Q2 to $54 million.Uzedy has fared well in the risperidone and long-acting markets, but Teva now aims to “compete in the broader market of schizophrenia,” Francis said on the call. “So, we’ll be looking for patients to benefit from this on other molecules currently,” he explained.The CEO reiterated that Teva aims to launch the anticipated second half of its long-acting schizophrenia portfolio—long-acting olanzapine—in 2026. Together, the company estimates that the long-acting schizophrenia franchise can deliver combined peak sales of $1.5 billion to $2 billion.The consistent growth of Teva’s innovative drug trio helps affirm the company’s multiyear turnaround thesis, Francis said.When Teva first telegraphed its new growth strategy some two years back, “there was a question mark,” Francis said in an interview following the company’s earnings call. “Can Teva sell innovative drugs? And now we continue to show quarter on quarter we can.” He added that “there’s no secret sauce to this,” explaining that the company is simply hitting on commercialization fundamentals and doing them well. The company’s generics business, meanwhile, fell 2% for the period. Teva called the comparison “flat,” as Francis attributed it to both the timing of shipments of generic Revlimid and a tough comparison to Teva’s second quarter in 2024, when the company benefited from the launch of its Victoza GLP-1 copycat.The company’s biosimilars business, on the other hand, is booming.“We’ve seen some really good sales momentum in the U.S., and that’s been driven by our established brands, as well as our new launches with Selarsdi and generic Soliris that we launched in Q1 this year,” Francis said on Teva's earnings call. Selarsdi is Teva’s biosimilar to Johnson & Johnson’s Stelara.Teva is planning two more biosimilar launches before the year is out.  “I think the thing that I’m seeing people take away is the transition from Teva as pure play generics to a biopharma company seemed like it was fiction two years ago,” Francis said in the interview with Fierce.“How could it be done,” he continued. “What we’re seeing now, with our ability to handle a flat generics quarter, because of our innovative growth, shows we’re well on our way to doing that, and I think that’s really exciting.” Editor's note: This story was updated with additional comments from an interview with Teva's CEO at 1:38 pm ET on July 30.