Caplyta Approval History
FDA Approved: Yes (First approved December 20, 2019)
Brand name: Caplyta
Generic name: lumateperone
Dosage form: Capsules
Company: Intra-Cellular Therapies, Inc.
Treatment for: Schizophrenia
Caplyta (lumateperone) is an atypical antipsychotic for the treatment of schizophrenia.
- The Caplyta product label carries a Boxed Warning for increased risk of mortality in elderly patients with dementia-related psychosis.
- The recommended dosage of Caplyta is one 42 mg capsule once daily with food.
- Common side effects include sleepiness and dry mouth.
Development History and FDA Approval Process for Caplyta
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