Jazz' Luvox PDUFA set for Feb 29

California, USA-based Jazz Pharmaceuticals says that the Food and Drug Administration has accepted for review the submission of the response by Belgium-headquartered Solvay Pharmaceuticals to the FDA approvable letter for once-a-day Luvox CR (fluvoxamine maleate) extended-release capsules. Solvay has been notified that the agency considers this a complete, class 1 response and the Prescription Drug User Fee Act action date is February 29. Jazz continues to expect to launch Luvox CR in the USA during the first quarter of 2008, subject to FDA approval.

The New Drug Application for seeks marketing approval for the treatment of obsessions and compulsions in patients with obsessive compulsive disorder and social anxiety disorder.

In January 2007, Jazz licensed the right to market Luvox CR and the immediate-release formulation in the USA from Solvay, which retains rights to both products in other territories around the world.