The sNDA submission is supported by positive results from two late-stage studies, Studies 501 and 502, that evaluated 42 mg of lumateperone as an adjunctive therapy to antidepressants for MDD.

(RTTNews) - Johnson & Johnson (JNJ), Tuesday announced that the U.S. Food and Drug Administration has approved supplemental New Drug Application or sNDA for Spravato, a monotherapy for adults with ...