Posted by Michael Wonder on 22 Feb 2022
AbbVie submits supplemental new drug application to U.S. FDA for cariprazine (Vraylar) for the adjunctive treatment of major depressive disorder
22 February 2022 - Submission is based on clinical trial results that include findings showing clinically and statistically significant improvement in the Montgomery-Åsberg Depression Rating Scale total score in patients with major depressive disorder treated with cariprazine (Vraylar) and an anti-depressant.
AbbVie today announced that it has submitted a supplemental new drug application for cariprazine (Vraylar) to the U.S. FDA for the adjunctive treatment of major depressive disorder in patients who are receiving on-going anti-depressant therapy.
