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

SOURCE Jazz Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2

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:4/18/2014)... A new study in the American Journal of ... searches reveals a recurring pattern that could be leveraged ... from San Diego State University, the Santa Fe Institute, ... Google searches (searches that included the term healthy and ... U.S. from 2005 to 2012. They found that on ...
(Date:4/17/2014)... Men who show signs of chronic inflammation in non-cancerous ... actually having prostate cancer than those with no inflammation, ... researchers from the Johns Hopkins Kimmel Cancer Center. , ... stronger for men with so-called high-grade prostate cancer ... indicating the presence of the most aggressive and ...
(Date:4/17/2014)... to a study published today in PLOS Pathogens ... where malaria is common can mount an immune response ... to avoid repeated bouts of high fever and illness ... their bloodstream. The findings may help researchers develop future ... the malaria parasite. , Each year, approximately 200 million ...
(Date:4/17/2014)... published in the April issue of Immunity , ... for Medical Research, says it,s time to take a ... treating sepsis, which kills millions worldwide every year, ... molecules released into the bloodstream to fight an injury ... necessary for maintaining good health without inflammation, wounds ...
(Date:4/17/2014)... MAYWOOD, Il. (April 17, 2014) Doctors who ... disease called lymphangioleiomyomatosis (LAM) can face an agonizing ... progression of the disease and help relieve shortness ... lung transplants, and sirolimus can cause potentially fatal ... said pulmonologist Dr. Daniel Dilling, medical director of ...
Breaking Medicine News(10 mins):Health News:New research shows people are thinking about their health early in the week 2Health News:Chronic inflammation linked to 'high-grade' prostate cancer 2Health News:Chronic inflammation linked to 'high-grade' prostate cancer 3Health News:Study sheds light on how the immune system protects children from malaria 2Health News:Feinstein Institute researcher publishes new perspective on sepsis 2Health News:Patients with rare lung disease face agonizing treatment dilemma 2Health News:Patients with rare lung disease face agonizing treatment dilemma 3
... Clinicians to Overcome the Limitations of Conventional Pulse Oximetry, ... Calif., June 3 Masimo, the inventor of Pulse ... announced it has completed the conversion of Duke ... , , "Ultimately, the decision to convert ...
... ... for Christian Community. Christian Care Ministry, Inc. is a not-for-profit religious organization that facilitates ... ... 2009 -- Medi-Share is a member-based program where members share in each ...
... Genetics is pleased to announce the launch of whole-genome ... Oligo Array, which is designed to identify chromosomal abnormalities ... partnership with Baylor College of Medicine , Ambry ... comprehensive, clinically-validated genetic tests available using array comparative genomic ...
... Lauded in Healthcare Category for ,Visionary Application of Information ... , , MADISON, N.J., June 3 ... world,s leading provider of diagnostic testing, information and services, ... Ltd. has been recognized as a Laureate by the ...
... , WASHINGTON, June 3 New questions and valuable answers ... at www.tenquestionstoanswer.org , the latest in the Heinz Family Philanthropies ... designed to help families make the best long-term care decisions. Available ... manage long-term care. , , "We want ...
... STAMFORD, Conn., June 3 FUJIFILM Medical Systems ... today that the company has taken several steps ... company is already an experienced virtualization provider with ... successfully implemented across the U.S. Now, to ...
Cached Medicine News:Health News:Leading University Hospital Completes System-Wide Conversion to Masimo SET(R) Pulse Oximetry 2Health News:Leading University Hospital Completes System-Wide Conversion to Masimo SET(R) Pulse Oximetry 3Health News:Leading University Hospital Completes System-Wide Conversion to Masimo SET(R) Pulse Oximetry 4Health News:Medi-Share Program Announces New Healthcare Program Offerings for Christian Community 2Health News:'Ambry Genetics Announces Launch of Chromosomal Microarray to Offer Whole Genome Analysis' 2Health News:'Ambry Genetics Announces Launch of Chromosomal Microarray to Offer Whole Genome Analysis' 3Health News:Quest Diagnostics India Recognized as Laureate by the Computerworld Honors Program 2Health News:Quest Diagnostics India Recognized as Laureate by the Computerworld Honors Program 3Health News:Quest Diagnostics India Recognized as Laureate by the Computerworld Honors Program 4Health News:New From the Heinz Family Philanthropies: 10 Questions and Valuable Answers to Help Families Manage Long-Term Care 2Health News:New From the Heinz Family Philanthropies: 10 Questions and Valuable Answers to Help Families Manage Long-Term Care 3Health News:New From the Heinz Family Philanthropies: 10 Questions and Valuable Answers to Help Families Manage Long-Term Care 4Health News:New From the Heinz Family Philanthropies: 10 Questions and Valuable Answers to Help Families Manage Long-Term Care 5Health News:Fujifilm Takes Virtualization Technology to Next Level 2Health News:Fujifilm Takes Virtualization Technology to Next Level 3
(Date:1/15/2014)... GARDENS, Fla. , Jan. 15, 2014  In an unprecedented effort ... and TB in ambulances and other transport vehicles, an advanced and ... by rescue personnel for the first time. In ... contact with these deadly pathogens, West Palm Beach ...
(Date:1/15/2014)... 2014 The Cadence Fitness & Health Center has ... Medical Fitness Association, a non-profit organization assisting medically integrated ... The Cadence Fitness & Health Center is the only ... in the Chicagoland area. "The certification means ...
(Date:1/15/2014)... LAVAL, Quebec , Jan. 15, 2014  Valeant Pharmaceuticals ... VRX) announced that the applicable waiting period under the ... to the previously announced tender offer by its indirect ... the outstanding shares of common stock of Solta Medical, ...
Breaking Medicine Technology:Superbugs No Longer Ride In Rescue Vehicles 2Cadence Fitness & Health Center Certified as Medical Fitness Facility 2Cadence Fitness & Health Center Certified as Medical Fitness Facility 3Valeant Pharmaceuticals Announces Receipt Of Antitrust Clearance For Its Previously Announced Acquisition Of Solta Medical, Inc. 2Valeant Pharmaceuticals Announces Receipt Of Antitrust Clearance For Its Previously Announced Acquisition Of Solta Medical, Inc. 3
... COLUMBUS, Ohio, June 15, 2011 EndoSphere Inc. ... and international issued and pending patents, announced today that ... company a patent covering the use of its endoscopically ... obesity and type 2 diabetes. U.S. Patent ...
... Corp. (the "Company") (NASDAQ OTC: VSHC) is pleased to be ... fourth quarter of fiscal 2011 to be between $1,050,000 and ... high since inception and represents a substantial increase from previous ... provide further guidance regarding year end revenues for the entire ...
Cached Medicine Technology:EndoSphere Inc. Receives Patent for Obesity Treatment 2Visual Healthcare Provides Fourth Quarter Revenue Guidance 2
Specimen-ID™, a Positive Specimen Identification System, assures the permanent link at the bedside between patient and laboratory specimen to prevent sample identification errors....
... The CAREt™ System is a ... state-of-the-art medication safety while improving ... assists in managing a myriad ... hand-held device linked real-time to ...
wCareMed™ utilizes barcode scanning technology to support medication administration. It is a simple to use point of care application that provides access to patient information on a lightweight,...
Med Administration Check closes the loop on the medication use process by automatically validating and documenting medication administration....
Medicine Products: