FDA approves new dosage strengths for bipolar, schizophrenia drug

The FDA has granted approval to Intra-Cellular Therapies Inc. for 10.5 mg and 21 mg dosages of lumateperone to treat schizophrenia and bipolar depression, according to a company release.
Lumateperone (Caplyta, Intra-Cellular) is indicated in adults as both monotherapy and adjunctive therapy with lithium or valproate and is available in 42 mg capsules, the company said in a press release.
“Caplyta 42 mg has demonstrated efficacy in the treatment of bipolar depression and schizophrenia with a favorable profile on weight, metabolic parameters and extrapyramidal symptoms (movement disturbances),”

The FDA has granted approval to Intra-Cellular Therapies Inc. for 10.5 mg and 21 mg dosages of lumateperone to treat schizophrenia and bipolar depression, according to a company release.
Lumateperone (Caplyta, Intra-Cellular) is indicated in adults as both monotherapy and adjunctive therapy with lithium or valproate and is available in 42 mg capsules, the company said in a press release.
“Caplyta 42 mg has demonstrated efficacy in the treatment of bipolar depression and schizophrenia with a favorable profile on weight, metabolic parameters and extrapyramidal symptoms (movement disturbances),”