(RTTNews) - Teva Pharmaceutical Industries Limited (TEVA) and Medincell (MEDCL) announced that the FDA has accepted their supplemental New Drug Application, or sNDA, for UZEDY extended-release injectable suspension.
The sNDA seeks approval for UZEDY as a maintenance treatment for Bipolar I Disorder or BP-I in adults.
UZEDY was approved for the treatment of schizophrenia in adults in April 2023. In its first full year of commercialization, the drug generated sales of $117 million in 2024.
If approved for the proposed expanded indication, UZEDY will provide a long-acting injectable treatment option for BP-I, a complex mental health disorder characterized by severe mood swings and debilitating symptoms.
Teva is leading the regulatory process and potential commercialization for UZEDY for BP-I, with Medincell eligible for royalties on sales.
The FDA decision is expected to be announced in the coming months.
TEVA closed Tuesday's (Feb.25 2025) trading at $16.61 down by 1.01 percent. In premarket trading Wednesday, the stock is up by 0.66 percent at $16.72 on the New York Stock Exchange.
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