Jazz Pharmaceuticals Inc. announced that the US Food and Drug Administration (FDA) has accepted for review the submission of the response by Solvay Pharmaceuticals, Inc. to the FDA approvable letter for Once-A-Day Luvox CR (fluvoxamine maleate) extended-release capsules.
The FDA has notified Solvay Pharmaceuticals that the agency considers this a complete, class 1 response and the PDUFA action date is February 29, 2008. Jazz Pharmaceuticals continues to expect to launch Luvox CR in the United States during the first quarter of 2008, subject to FDA approval.
In an approvable letter received on December 21, 2007, the FDA requested additional information concerning a CMC issue. Jazz Pharmaceuticals and Solvay Pharmaceuticals believe that the response submitted to the FDA on December 28, 2007 fully addressed that CMC issue. The approvable letter did not raise any questions related to safety or efficacy of Luvox CR and included the FDA's proposed labeling.
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.
Luvox is a registered trademark of Solvay Pharmaceuticals, Inc.