PALO ALTO, Calif., Jan. 31 Jazz Pharmaceuticals,Inc. (Nasdaq: JAZZ) announced today that the U.S. Food and Drug Administration(FDA) has accepted for review the submission of the response by SolvayPharmaceuticals, Inc. to the FDA approvable letter for Once-A-Day LUVOX(R) CR(fluvoxamine maleate) Extended-Release Capsules. The FDA has notified SolvayPharmaceuticals that the Agency considers this a complete, class 1 responseand the PDUFA action date is February 29, 2008. Jazz Pharmaceuticalscontinues to expect to launch LUVOX CR in the United States during the firstquarter of 2008, subject to FDA approval.
In an approvable letter received on December 21, 2007, the FDA requestedadditional information concerning a CMC issue. Jazz Pharmaceuticals andSolvay Pharmaceuticals believe that the response submitted to the FDA onDecember 28, 2007 fully addressed that CMC issue. The approvable letter didnot raise any questions related to safety or efficacy of LUVOX CR and includedthe FDA's proposed labeling.
The NDA for LUVOX CR seeks marketing approval for the treatment ofobsessions and compulsions in patients with obsessive compulsive disorder(OCD) and for the treatment of social anxiety disorder (SAD). LUVOX CR is anextended-release formulation of fluvoxamine maleate, a selective serotoninreuptake inhibitor.
About Jazz Pharmaceuticals, Inc.
Jazz Pharmaceuticals, Inc. is a specialty pharmaceutical company focusedon identifying, developing and commercializing innovative products to meetunmet medical needs in neurology and psychiatry. For further information,please visit http://www.JazzPharmaceuticals.com.
LUVOX is a registered trademark of Solvay Pharmaceuticals, Inc.
"Safe Harbor" Statement under the Private Securities Litigation Reform Actof 1995
This press release contains forward-looking statements, including, but notlimited to, statements related to the implications of the approvable letterfor LUVOX CR. These forward-looking statements inherently involve significantrisks and uncertainties. Jazz Pharmaceuticals' actual results and the timingof events could differ materially from those anticipated in suchforward-looking statements as a result of these risks and uncertainties, whichinclude, without limitation, whether or when LUVOX CR will be approved orlaunched. These and other risk factors are discussed under "Risk Factors," inthe Quarterly Report on Form 10-Q for the quarter ended September 30, 2007filed by Jazz Pharmaceuticals with the Securities and Exchange Commission onNovember 9, 2007. Jazz Pharmaceuticals undertakes no duty or obligation toupdate any forward-looking statements contained in this release as a result ofnew information, future events or changes in its expectations.
SOURCE Jazz Pharmaceuticals, Inc.