Advertisement
The FDA requested information related to the companies' responseconcerning the previously disclosed CMC issue. The companies are seekingclarification from FDA and look forward to working with FDA to resolve this asquickly as possible. The approvable letter did not raise any questionsrelated to safety or efficacy of LUVOX(R) CR. The approvable letter includedthe FDA's proposed labeling.
Advertisement
Separately, the FDA approved LUVOX(R) (fluvoxamine maleate) for thetreatment of OCD on December 20, 2007.
Jazz Pharmaceuticals will host an investor conference call and live audiowebcast to discuss this corporate update on December 24, 2007 at 8:30 a.m.Eastern Time/5:30 a.m. Pacific Time. The live webcast and press release maybe accessed on Jazz Pharmaceuticals' website athttp://www.JazzPharmaceuticals.com. Please connect to the website prior tothe start of the conference call to ensure adequate time for any softwaredownloads that may be necessary. An archived version of the webcast will beavailable through January 7, 2008. Investors may participate in theconference call by dialing 1-866-383-8009 in the U.S., or 1-617-597-5342outside the U.S., and entering passcode 31811188. A replay of this call willbe available until January 7, 2008 at 1-888-286-8010 (U.S.), or 1-617-801-6888(international), using the passcode 32600407.
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 such forward-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.
