Vocabria Gains New Indication for HIV Prevention
December 20, 2021Leqvio Approved as Adjunct Therapy to Lower Cholesterol
December 22, 2021December 20, 2021 – Caplyta® (lumateperone – Intra-Cellular Therapies) oral capsules are now approved to treat depressive episodes associated with bipolar I or II disorder (bipolar depression) in adults, either as a monotherapy or as an adjunctive therapy with lithium or valproate.
- First FDA approved in 2019, Caplyta is also indicated to treat schizophrenia in adults.
- Recommended dosing is one 42mg capsule taken by mouth once daily.
- In addition to the new indication, Caplyta has received an expanded black box warning, the most prominent warning the FDA can require on a drug’s label, to caution that antidepressants may increase the risk of suicidal thoughts and behaviors in pediatric and young adult patients.