Abbvie seeks to add major depressive disorder to drug label

Abbvie has filed a supplemental marketing authorization application with the FDA to expand the indication of cariprazine to include major depressive disorder.

Photo: Abbvie / PR

On Wednesday, US-based Abbvie has filed a supplemental drug application with the US Food and Drug Administration (FDA) to have cariprazine approved for the adjunctive treatment of major depressive disorder (MDD), a company press release reports.

”[The] submission is based on clinical trial results that include findings showing clinically and statistically significant improvement in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score in patients with major depressive disorder treated with cariprazine and an antidepressant,” the company writes.

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