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Jazz submits complete responses for Luvox

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Jazz Pharmaceuticals announces FDA's acceptance of a complete response to an "approvable" letter for Luvox CR (fluvoxamine maleate extended-release capsules), setting a user fee date at December 22. The NDA seeks claims for treatment of obsessive compulsive disorder and social anxiety disorder. FDA also has accepted the submission of Solvay Pharmaceuticals' complete response to its approvable letter for Luvox immediate-release tablets, setting the action date at December 21. Jazz licensed U.S. marketing rights to Luvox CR and Luvox from Solvay in January. Jazz expects to launch Luvox CR in the U.S. during the first quarter of 2008. The firm had its initial public offering in May (1Pharmaceutical Approvals Monthly June 2007, p. 6)...

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