Caplyta is a brand-name prescription drug used to treat certain mental health conditions. It is a type of drug called an atypical antipsychotic. If a person has a Part D prescription drug plan or a ...

The U.S. Food and Drug Administration has approved the expanded use of Johnson & Johnson‘s Caplyta as an add-on treatment for adults with major depressive disorder. Following the FDA’s Nov. 5 decision ...

NEW YORK, Dec. 23, 2019 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (Nasdaq:ITCI), a biopharmaceutical company focused on the development of therapeutics for central nervous system (CNS) ...

ITCI submits Supplemental New Drug Applications (sNDAs) for the treatment of depressive episodes associated with bipolar I or II disorder both as monotherapy and as adjunctive therapy in adults. If ...

TITUSVILLE, N.J., April 27, 2026 /PRNewswire/ -- Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) based on ...

Please provide your email address to receive an email when new articles are posted on . Caplyta had been previously approved by FDA for bipolar I and II depression and schizophrenia. Approval was ...

Intra-Cellular's share price has increased by 450% over a five-year period and over 50% in the past year. The company's success is attributed to its approved drug, Caplyta, which has driven ...

The sNDA submission is based on positive results from Studies 501 and 502 demonstrating CAPLYTA’s robust antidepressant efficacy and favorable safety and tolerability profile CAPLYTA, if approved as ...

High placebo responses common in tests of neuropsychiatric drugs make any clinical trial in major depressive disorder risky. Intra-Cellular Therapies now has data showing its drug met key goals of a ...

Caplyta is a brand-name prescription medication containing the active ingredient lumateperone. Currently, no generic version of the medication is available. An important note about Caplyta for older ...