AbbVie’s Vraylar Gets Expanded Approval for Major Depressive Disorder

The FDA has expanded its approval for AbbVie’s blockbuster antipsychotic drug Vraylar (cariprazine), this time as an adjunctive treatment along with antidepressants to treat adults with major depressive disorder.

Vraylar may now be offered to adults with major depressive disorder who have a partial response when taking an antidepressant. The FDA’s expanded approval was supported by phase 3 study results.

Vraylar, an atypical antipsychotic, is now FDA-approved for four indications.

AbbVie reported sales of more than $1.7 billion for Vraylar in 2021.