FDA accepts Teva and Medincell’s Uzedy sNDA
Israel-headquartered Teva Pharmaceutical Industries’ (NYSE/TASE: TEVA) US subsidiary and France’s Medincell (Euronext: MEDCL) announced that the supplemental New Drug Application (sNDA) for Uzedy (risperidone) extended-release injectable suspension for the maintenance treatment of bipolar-I (BP-I) in adults has been accepted for filing by the US Food and Drug Administration (FDA).
If approved, it could be one of the few long-acting injectable (LAI) treatment options available for the more than 3.4 million Americans impacted by this condition, the companies noted.
The sNDA is based on leveraging the existing clinical data for Uzedy coupled with the FDA’s previous findings of safety and efficacy of past risperidone formulations approved for the treatment of BP-I. Already approved and marketed as a schizophrenia drug, Uzedy posted revenues of $117 million in 2024, surpassing the $100million outlook.
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