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:6/27/2016)... ... June 27, 2016 , ... TherapySites, the ... affiliation with Tennessee Counseling Association. This new relationship allows TherapySites to ... Counseling Association, adding exclusive benefits and promotional offers. , "TCA is extremely excited ...
(Date:6/27/2016)... ... June 27, 2016 , ... TopConsumerReviews.com recently awarded their highest five-star ... , Millions of individuals in the United States and Canada wear eyeglasses. Once considered ... both correct vision and make a fashion statement. Even celebrities use glasses as a ...
(Date:6/26/2016)... ... 26, 2016 , ... Pixel Film Studios Released ProSlice Levels, a Media Slicing ... their videos a whole new perspective by using the title layers in ProSlice ... , ProSlice Levels contains over 30 Different presets to choose from. FCPX ...
(Date:6/26/2016)... ... June 26, 2016 , ... Many women ... diagnosed with endometriosis. These women need a treatment plan to not only alleviate ... that can help for preservation of fertility and ultimately achieving a pregnancy. The ...
(Date:6/25/2016)... ... ... Bruton Memorial Library on June 21 due to a possible lice infestation, as reported by ... lice: the parasite’s ability to live away from a human host, and to infest common ... the event that lice have simply gotten out of control. , As lice are a ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... 2016 Research and Markets ... Electronics 2015-2025: Applications, Technologies, Forecasts" report to ... In-Mold Electronics, Smart Skin, Structural Health Monitoring, Composite ... Structural electronics involves electronic and/or electrical components and ... dumb structures such as vehicle bodies or conformally ...
(Date:6/24/2016)... BEIJING , June 24, 2016 Dehaier ... or the "Company"), which develops, markets and sells medical ... China , signed a strategic cooperation agreement with ... as "Hongyuan Supply Chain") on June 20, 2016, to ... Under the strategic cooperation agreement, Dehaier will leverage Hongyuan ...
(Date:6/24/2016)... Research and Markets has announced the ... Tests" report to their offering. ... The World Market for Companion Diagnostics covers the ... analysis in the report includes the following: ... Kits) by Region (N. America, EU, ROW), 2015-2020 , ...
Breaking Medicine Technology: