Viatris (VTRS) said Monday that it filed supplemental new drug applications to Japan's Ministry of Health, Labor and Welfare for approval of Effexor SR Capsules to treat adults with generalized anxiety disorder.
The application follows a phase 3 randomized, double-blind study in Japan which met its primary objective of superiority over a placebo at eight weeks as well as seven secondary efficacy endpoints, the company said.
Effexor is currently approved in Japan to treat major depressive disorder in adults, Viatris said.