Posted by Michael Wonder on 26 Apr 2022
Intra-Cellular Therapies announces FDA approval of new dosage strengths for Caplyta (lumateperone) for specific patient populations
25 April 2022 - Caplyta label now includes dosage recommendations for specific patient populations; those with moderate or severe hepatic impairment and patients who are concomitantly taking moderate or strong CYP3A4 inhibitors.
Intra-Cellular Therapies today announced that the U.S. FDA approved two new dosage strengths of Caplyta, 10.5 mg and 21 mg capsules, to provide dosage recommendations for patients concomitantly taking strong or moderate CYP3A4 inhibitors, and 21 mg for patients with moderate or severe hepatic impairment (Child-Pugh class B or C).
