FDA accepts for review NDA for lumateperone to treat schizophrenia.-Intra-Cellular Therapies
Intra-Cellular Therapies announced that the FDA has accepted for review its New Drug Application (NDA) for lumateperone, an investigational agent for the treatment of schizophrenia. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of September 27, 2019.
The lumateperone NDA for the treatment of schizophrenia is supported by data from 20 clinical trials and more than 1,900 subjects exposed to lumateperone. Lumateperone received Fast Track designation from the FDA in November 2017 for the treatment of schizophrenia.
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