Fluvoxamine maleate

From WikiCover

On August 2, 2007, Jazz Pharmaceuticals announced today that the FDA has accepted for review the submission of the complete response by Solvay Pharmaceuticals to the FDA approvable letter for Luvox CR (fluvoxamine maleate) extended-release capsules. The PDUFA action date is December 22, 2007.

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

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 PDUFA action date is December 21, 2007.

In January 2007, Jazz Pharmaceuticals licensed from Solvay Pharmaceuticals the right to market Luvox CR and Luvox in the United States. Solvay Pharmaceuticals retains the right to market both products in other territories around the world. Subject to receipt of FDA approval, Jazz Pharmaceuticals expects to launch Luvox CR in the United States during the first quarter of 2008.