Teva Pharmaceutical Receives FDA Approval to Expand UZEDY Indication for Maintenance Treatment of Bipolar I Disorder

Teva Pharmaceutical Industries Limited (NYSE:TEVA) is one of the best high volume stocks to buy according to Wall Street analysts. On October 10, the US FDA approved an expanded indication for UZEDY (risperidone) extended-release injectable suspension for subcutaneous use. This announcement was made by Teva Pharmaceutical Industries and Medincell grants approval for UZEDY as a monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder (BD-I) in adults.

This is a significant step toward addressing unmet needs for those living with BD-I, a serious mental health condition defined by episodes of mania and depression, affecting an estimated 1% (or 3,400,000+) of US adults in their lifetime. UZEDY is a long-acting formulation of risperidone that utilizes SteadyTeq, a proprietary copolymer technology from Medincell, which controls the steady release of the medication. Therapeutic blood concentrations are reached within 6-24 hours of a single dose.

For the newly approved BD-I indication, UZEDY is approved with three once-monthly dosing options: 50 mg, 75 mg, and 100 mg. For its prior indication, UZEDY is also available for use every one or two months for the treatment of schizophrenia in adults, an indication it received US approval in 2023. The FDA’s decision to expand UZEDY’s indication was based on existing clinical data for the drug.

Teva Pharmaceutical Industries Limited (NYSE:TEVA) develops, manufactures, markets, and distributes generic and other medicines and biopharmaceutical products in the US, Europe, Israel, and internationally.

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Disclosure: None. This article is originally published at Insider Monkey.