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 ...

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Shares in Intra-Cellular Therapies rose sharply after it reported that its only product Caplyta was effective for a new indication, major depressive disorder (MDD), in a phase 3 trial.

The settlement gives Sandoz rights to generic versions of Caplyta in the US, but only after 1st July 2040 (or earlier in certain circumstances). Other patent litigation remains pending in the US.