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 ...

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

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 ...

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

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

Caplyta may cause problems with body temperature, making it difficult for your body to cool down (heat intolerance).Heavy exercise, extreme heat, dehydration, and certain medicines may worsen heat ...

CAPLYTA is an oral, once daily medicine approved for the treatment of schizophrenia in adults (42mg/day). The mechanism of action of CAPLYTA in the treatment of schizophrenia is unknown.

Caplyta's exceptional tolerability sets it apart from other antipsychotics, with a low incidence of weight gain, metabolic abnormalities, and movement disorders like tardive dyskinesia, making it ...

Caplyta (lumateperone) is a brand-name oral capsule that’s prescribed for schizophrenia and bipolar depression in adults. If you have problems with side effects from Caplyta, talk with your ...

Caplyta may not be safe to take while pregnant or breastfeeding. Keep reading to learn more about Caplyta and reproductive health. And for a detailed overview of this drug, check out this article .