FDA accepts application for Takeda, Lundbeck antidepressant
DEERFIELD, Ill. — The Food and Drug Administration has accepted a regulatory approval application from Takeda and Lundbeck for an experimental drug to treat depression, the companies said Wednesday.
The FDA will review the companies' application for vortioxetine for the treatment of major depressive disorder in adults. The agency expects to finish reviewing the application by Oct. 2, 2013.
The application includes data from seven studies that included more than 7,500 patients ages 18 to 88 years. The companies have proposed marketing the drug under the name Brintellix if it wins approval.