SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
January 31, 2008
Date of Report (Date of earliest event reported)
JAZZ PHARMACEUTICALS, INC.
(Exact name of Registrant as specified in its charter)
(State or Other Jurisdiction
|(Commission File No.)|| |
3180 Porter Drive, Palo Alto, California 94304
(Address of principal executive offices, including zip code)
(Registrants telephone number, including area code)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
|¨||Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)|
|¨||Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)|
|¨||Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))|
|¨||Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))|
Item 8.01 Other Events.
On January 31, 2008, Jazz Pharmaceuticals, Inc. announced that the U.S. 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, as a complete Class 1 response. The PDUFA date is February 29, 2008. A copy of the press release is attached as Exhibit 99.1 to this current report and is incorporated by reference herein.
Item 9.01 Financial Statements and Exhibits.
|99.1||Press Release dated January 31, 2008|
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|JAZZ PHARMACEUTICALS, INC.|
|Carol A. Gamble|
|Senior Vice President, General Counsel|
|and Corporate Secretary|
Date: January 31, 2008
|Press Release dated January 31, 2008|
JAZZ PHARMACEUTICALS, INC. ANNOUNCES SUBMISSION OF COMPLETE
RESPONSE TO FDA APPROVABLE LETTER FOR LUVOX® CR
PDUFA DATE SET FOR FEBRUARY 29, 2008
PALO ALTO, Calif., January 31, 2008Jazz 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 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 FDAs 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.
About Jazz Pharmaceuticals, Inc.
Jazz Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on identifying, developing and commercializing innovative products to meet unmet 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 Act of 1995
This press release contains forward-looking statements, including, but not limited to, statements related to the implications of the approvable letter for LUVOX CR. These forward-looking statements inherently involve significant risks and uncertainties. Jazz Pharmaceuticals actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, whether or when LUVOX CR will be approved or launched. These and other risk factors are discussed under Risk Factors, in the Quarterly Report on Form 10-Q for the quarter ended September 30, 2007 filed by Jazz Pharmaceuticals with the Securities and Exchange Commission on November 9, 2007. Jazz Pharmaceuticals undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events or changes in its expectations.
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BCC Partners on behalf of Jazz Pharmaceuticals, Inc.
Karen L. Bergman, 650-575-1509
Michelle Corral, 415-794-8662
Jazz Pharmaceuticals, Inc.
Jim Karrels, Executive Director, Finance