Johnson & Johnson (NYSE:JNJ) submitted a supplemental New Drug Application for CAPLYTA®, aiming to prevent schizophrenia ...

Titusville: Johnson & Johnson has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug ...

The supplemental New Drug Application is supported by Phase III data, which showed Caplyta significantly prolonged time to ...

Johnson & Johnson submits sNDA to US FDA for Caplyta for prevention of relapse in schizophrenia: Titusville, New Jersey Wednesday, July 9, 2025, 14:00 Hrs [IST] Johnson & Johnson ...

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Welcome to Fierce Pharma's regulatory tracker for the second half of 2025. | In this tracker, Fierce Pharma is recording the ...

CAPLYTA is already FDA-approved for treating schizophrenia and depressive episodes associated with bipolar I or II disorder, both as monotherapy and as adjunctive therapy with lithium or valproate.

Johnson & Johnson (JNJ) said on Tuesday that it has submitted a supplemental new drug application to the U.S. Food and Drug ...

A 49-study meta-analysis showed that the mean number of discontinuation symptoms 1 week after stopping an antidepressant was ...

Caplyta is usually taken as a 42-milligram capsule once daily, with or without food. But the dose may be decreased to 10.5 milligrams or 21 milligrams daily, depending on certain other drugs you ...

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Caplyta may cause serious side effects, but these are not common. The following list may not include all possible serious side effects of the drug. For more information, you can refer to Caplyta ...