New approval for schizophrenia and bipolar I disorder.
The US Food and Drug Administration has approved Luye Pharma’s Rykindo (risperidone) for extended-release injectable suspension for schizophrenia treatment in adults, and as monotherapy or as adjunctive therapy to lithium or valproate for bipolar I disorder maintenance treatment in adults.
The drug is administered via intramuscular injection every 2 weeks and delivers risperidone via long-acting and extended-release microsphere technology.
“Mental disorders including schizophrenia and bipolar disorder not only seriously affect the physical and mental health of patients, but also impose a heavy burden on their families and the society. Rykindo is our first new drug developed in-house and approved for marketing in the U.S., demonstrating our long-standing commitment to serving patients around the world with innovative therapies,” said Yang Rongbing, President of Luye Pharma Group.
1. Luye Pharma. FDA approves Luye Pharma's Rykindo® for the treatment of schizophrenia and bipolar 1 disorder. News release. January 15, 2023. Accessed January 17, 2023. https://www.prnewswire.com/news-releases/fda-approves-luye-pharmas-rykindo-for-the-treatment-of-schizophrenia-and-bipolar-1-disorder-301721891.html