Intra-cellular therapies announces fda acceptance of caplyta® (lumateperone) sndas for the treatment of bipolar depression

New york, may 03, 2021 (globe newswire) -- intra-cellular therapies, inc. (nasdaq: itci), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (cns) disorders, today announced that the u.s. food and drug administration (fda) has accepted for review its supplemental new drug applications (sndas) for lumateperone, an investigational agent for the treatment of depressive episodes associated with bipolar i or ii disorder (bipolar depression) as monotherapy and as adjunctive therapy with lithium or valproate. the fda has assigned a prescription drug user fee act (pdufa) target action date of december 17, 2021 for the applications. if approved, caplyta has the potential to be an important medicine for a broad group of patients suffering from these highly prevalent, chronic complex conditions.
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