Navigation Links
Jazz Pharmaceuticals, Inc. Announces Submission of Complete Response to FDA Approvable Letter for LUVOX(R) CR
Date:1/31/2008

PDUFA Date Set for February 29, 2008

PALO ALTO, Calif., Jan. 31 /PRNewswire-FirstCall/ -- 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 Solvay Pharmaceuticals, Inc. to the FDA approvable letter for Once-A-Day LUVOX(R) 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 FDA's 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.


'/>"/>
SOURCE Jazz Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. Acura Pharmaceuticals, Inc. Announces Approval to List Shares on NASDAQ and Effective Feb. 4, 2008 a New Trading Symbol: ACUR
2. Acura Pharmaceuticals, Inc. Announces Appointment of George K. Ross as Director
3. Access Licenses MuGard(TM) to RHEI Pharmaceuticals, a Leading Specialty Pharmaceutical Company for Distribution in China and Certain Other Southeast Asian Countries
4. American Stock Exchange LLC to Delist Securities of Samaritan Pharmaceuticals, Inc.
5. Law Offices of Howard G. Smith Announces 25 Days Remaining to Move to Be a Lead Plaintiff in the Shareholder Lawsuit Against Threshold Pharmaceuticals, Inc.
6. Alseres Pharmaceuticals, Inc. to Present at New York Society of Security Analysts Conference
7. Keryx Biopharmaceuticals, Inc. Announces Poster Presentations Highlighting Observed Clinical Activity of KRX-0401 (Perifosine) to be Presented at the Upcoming American Society of Hematology Meeting in Atlanta, Georgia
8. Acura Pharmaceuticals, Inc. Announces Implementation of Reverse Stock Split and New Trading Symbol: ACPH
9. Jazz Pharmaceuticals, Inc. Announces Third Quarter 2007 Financial Results
10. Elan Pharmaceuticals, Inc. Licenses Software and Databases From GeneGo
11. Anthera Pharmaceuticals, Inc. Appoints Donald Santel to Board of Directors
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2017)... ... June 24, 2017 , ... ... PA at the Sheraton Erie Bayfront and Erie Convention Center on June 8-10. ... experience, exhibits, a student quiz bowl, award and scholarship presentations, and professional networking. ...
(Date:6/23/2017)... ... June 23, 2017 , ... ... the launch of Care Management Alerts and Dashboards, an innovative new service enabling ... Island. , RIQI’s Care Management Alerts and Dashboards provide near real-time data about ...
(Date:6/23/2017)... ... ... Studies show evidence that carotenoids and antioxidants derived either from the diet or ... But how often do ophthalmologists and optometrists in Sweden recommend the use of nutritional ... early symptoms of AMD? A study published recently in Dove Medical Press ...
(Date:6/23/2017)... ... June 23, 2017 , ... Everybody has their own personal preference when ... read it, and some people don't like it at all. FindaTopDoc took a look ... , Erotic literature can give readers a taste of their deepest, darkest fantasies and ...
(Date:6/23/2017)... Georgia (PRWEB) , ... June 23, 2017 , ... ... Negative Breast Cancer Conference from Sept. 18 to 20. , The two-day conference ... (TNBC) subtype with the goal of improving patients’ lives and eliminating racial breast ...
Breaking Medicine News(10 mins):
(Date:6/5/2017)... , June 5, 2017 The Cincinnati ... of Diplomat Pharmacy, Inc. (NYSE: DPLO), has been awarded a ... Enquirer . Results are based on an employee ... organizational health and workplace improvement. The survey measures several aspects ... ...
(Date:6/1/2017)... , June 1, 2017 Nutriceutical Holdings (NH), ... Recommended Solutions (VRS), and KD Pharma Group have decided ... Holdings by KD Pharma Group. KD Pharma Group will ... option to acquire the entire company. "We ... They are committed to growing the NH companies by ...
(Date:5/29/2017)... AVIV, Israel, May 29, 2017  Cellect Biotechnology Ltd. ... innovative technology which enables the functional selection of stem ... results for the first quarter ended March 31 st ... with our accomplishments in the first quarter of 2017," ... first quarter, we announced the treatment of the first ...
Breaking Medicine Technology: