The new product, which carries an AB therapeutic equivalence rating to the reference listed drug Luvox CR, is available in 30-count bottles. This expansion follows the company’s integration into the Bora Pharmaceuticals group, reflecting a broader strategy to scale its commercial infrastructure.

Clinical use of the medication carries a boxed warning regarding the risk of suicidal thinking and behavior in children, adolescents, and young adults. Prescribers are advised to monitor patients closely for clinical worsening or behavioral changes. Detailed prescribing information and reporting procedures for adverse reactions are available through the manufacturer or the FDA MedWatch program.