FDA Accepts Complete Responses to Approvable Letters for Luvox

Jazz Pharmaceuticals announced that the FDA has accepted for review the submission of the complete response by Solvay Pharmaceuticals to the FDA approvable letter for Luvox CR extended-release capsules.

According to Jazz, the agency’s action date is Dec. 22.

The new drug application for Luvox CR (fluvoxamine maleate) seeks marketing approval for the treatment of obsessions and compulsions in patients with obsessive compulsive disorder and for the treatment of social anxiety disorder, the company said. Luvox CR is an extended-release formulation of fluvoxamine maleate, a selective serotonin reuptake inhibitor, the company added.

According to the company, the FDA has also accepted the submission of the complete response by Solvay Pharmaceuticals to the FDA approvable letter for Luvox (fluvoxamine maleate) immediate release tablets. The action date is Dec. 21, the company added.