Navigation Links
Jazz Pharmaceuticals Provides Update on FDA Advisory Committee Meeting For JZP-6 (Sodium Oxybate) in Fibromyalgia
Date:8/20/2010

PALO ALTO, Calif., Aug. 20 /PRNewswire-FirstCall/ -- Jazz Pharmaceuticals, Inc. (Nasdaq: JAZZ) announced today that the Joint Advisory Committee of the U.S. Food and Drug Administration (FDA), including the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee, voted 20-2 that the benefit/risk balance did not support the approval of JZP-6 for the treatment of fibromyalgia with the currently proposed Risk Evaluation Mitigation Strategy (REMS).

"While we are disappointed with the recommendation of the Joint Advisory Committee, we plan to work closely with FDA on the continuing review of our new drug application (NDA)," said Bruce Cozadd, Chairman and CEO of Jazz Pharmaceuticals, Inc.  "We will carefully consider the input of the Committee as we seek to address the needs of fibromyalgia patients for new treatment options in a safe and responsible way."

Company to Host Teleconference on Monday, August 23

Jazz Pharmaceuticals will hold a teleconference and webcast for the investment community at 8:30 a.m. EDT (5:30 a.m. PDT) on Monday, August 23 to discuss the outcome of the FDA advisory committee meeting.  Investors may participate in the conference call by dialing 866.713.8566 in the U.S., or 617.597.5325 outside the U.S., and entering 35059911.  

A live webcast of the teleconference may be accessed from the Investors section of the Jazz Pharmaceuticals website at www.jazzpharmaceuticals.com. Please connect to the website prior to the start of the conference call to ensure adequate time for any software downloads that may be necessary to listen to the webcast.

About Jazz Pharmaceuticals, Inc.

Jazz Pharmaceuticals (Nasdaq: JAZZ) is a specialty pharmace
'/>"/>

SOURCE Jazz Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2

Related medicine technology :

1. Cumberland Pharmaceuticals Announces Extension of FDA Review of Acetadote® Supplemental New Drug Application
2. Shareholder Class Action Filed Against SciClone Pharmaceuticals, Inc. by the Law Firm of Barroway Topaz Kessler Meltzer & Check, LLP
3. Optimer Pharmaceuticals Fidaxomicin Marketing Authorization Application Accepted for Review by European Medicines Agency
4. Quark Pharmaceuticals and Major Pharmaceutical Company Enter into Licensing Option Agreement for the p53 Suppressor Drug QPI-1002, the First siRNA Administered Systemically in Human
5. Biostar Pharmaceuticals, Inc. Second Quarter Revenue Increased 46.4% to $19.4 Million
6. Trubion Pharmaceuticals Inc. Reports Second-Quarter and First-Half 2010 Financial Results
7. Cumberland Pharmaceuticals Reports Second Quarter 2010 Financial Results
8. Ferring Pharmaceuticals FIRMAGON® Joins Race to End Prostate Cancer as Official Sponsor of the Great Prostate Cancer Challenge / Dash for Dad
9. Jiangbo Pharmaceuticals Announces the Commercial Launch of Felodipine Sustained Release Tablets
10. Lotus Pharmaceuticals Reports Strong Second Quarter 2010 Financial Results
11. Titan Pharmaceuticals Announces Second Quarter 2010 Financial Results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/17/2014)... , Sept. 17, 2014 Germany ... Summary GlobalData,s new report, "Germany Gynecological Devices ... on the Germany Gynecological Devices market. The report ... (in units) and average prices (in US dollars) ... Sterilization Devices (Micro-inserts) and Mechanical Sterilization Devices (Tubal ...
(Date:9/17/2014)... , Sept. 17, 2014  Levi & Korsinsky, ... connection with possible claims of breaches of fiduciary duty ... To get more information, click here: http://zlk.9nl.com/alexza-pharmaceuticals-alxa ... If you own common stock in Alexza ... contact Eduard Korsinsky, Esq. either via email ...
(Date:9/17/2014)... 2014 Pomerantz LLP is investigating claims on ... or the "Company") (NASDAQ: PDLI).  Such investors are advised ... rswilloughby@pomlaw.com or 888-476-6529, ext. 237. The ... officers and/or directors have violated Sections 10(b) and 20(a) ... On September 17, 2014, the Company announced that ...
Breaking Medicine Technology:Germany Gynecological Devices Market Outlook to 2020 2Germany Gynecological Devices Market Outlook to 2020 3SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of PDL BioPharma, Inc. - PDLI 2
... chemotherapy-soaked beads to choke off and kill cancerous ... research being presented at the 21st annual International ... a minimally invasive therapy that takes a two-pronged ... minimally invasive methods to deliver the beads (also ...
... ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA ), today announced ... solution) has been accepted for review by the U.S. Food ... for Bepreve as an eye drop treatment for ocular itching ... review of ten months and has been given a user ...
Cached Medicine Technology:Chemoembolization Improving as Liver Cancer Treatment 2Chemoembolization Improving as Liver Cancer Treatment 3Chemoembolization Improving as Liver Cancer Treatment 4ISTA Pharmaceuticals' New Drug Application for Bepreve(TM) Accepted for Review by U.S. Food and Drug Administration 2ISTA Pharmaceuticals' New Drug Application for Bepreve(TM) Accepted for Review by U.S. Food and Drug Administration 3
(Date:9/18/2014)... (PRWEB) September 18, 2014 First ... freestanding emergency rooms in the United States, named Douglas ... new Missouri City-Lakes facility. , “We are pleased ... facility medical director of our new Missouri City-Lakes facility,” ... First Choice Emergency Room. , Dr. Harrison received ...
(Date:9/18/2014)... 18, 2014 9Lover.com, an internationally well-known ... recently launched a big promotion for its maternity wedding ... can buy discounted maternity wedding dresses on ... appreciation to all global consumers. The company’s development manager ... lot of ladies delighted. The current special offer will ...
(Date:9/17/2014)... 2014 A ball gown is the ... traditionally a full-skirted gown reaching the floor, made of ... well-known special occasion gown manufacturer and retailer, has delightedly ... gorgeous ball gowns are offered at discounted rates. , ... necklines. Such gowns are typically worn with a stole ...
(Date:9/17/2014)... The National Resident Matching Program has published ... analysis of the relationship between unique applicant characteristics and ... new edition is based on the 2014 Main Residency ... medical school senior students and all other applicants. , ... this new edition of Charting Outcomes in the Match,” ...
(Date:9/17/2014)... 2014 In its latest blog post, ... alcohol treatment program that gets clients off to a ... recovery they can believe in, is exploring the dangerous ... Americans who are afflicted with depression are also addicted ... CEO Per Wickstrom . “Unfortunately, these two very ...
Breaking Medicine News(10 mins):Health News:First Choice Emergency Room Announces Dr. Douglas J. Harrison as Medical Director of Missouri City - Lakes, Texas Facility 2Health News:Discounted Maternity Wedding Dresses For 2014 Introduced By 9Lover.com 2Health News:Fecbek.com: Ladies Can Be Elegant Enough to Draw Everyone’s Attention by Wearing Trendy Ball Gowns 2Health News:Just Released: Charting Outcomes in the Match for the 2014 Main Residency Match® 2Health News:Just Released: Charting Outcomes in the Match for the 2014 Main Residency Match® 3Health News:Latest A Forever Recovery Blog Post Explores the Link Between Addiction and Depression 2Health News:Latest A Forever Recovery Blog Post Explores the Link Between Addiction and Depression 3
... ... as Vice President of Sales. Separately, Kardea has announced that it has extended ... ... LLC announced today that Robert Lukasik has joined the company as Vice President of Sales. ...
... , WASHINGTON , Feb. 15 ... U.S. Census Bureau: , (Logo: http://www.newscom.com/cgi-bin/prnh/20090226/CENSUSLOGO ) , ... , Profile America — Monday, February 15th . ... became the first American to win the women,s World Figure Skating ...
... a hospital is in orthopedic surgical care, the better the ... replacement surgery, University of Iowa researchers report in a new ... were fewer serious post-surgical complications such as blood clots, infections ... The findings, which were published online Feb. 11 by the ...
... , TEMPE, Ariz. , Feb. 14 Local ... efforts to benefit breast cancer research and the Susan G. Komen ... beginning at 8:30am . , "Change Your ... kid zone event hosted by ASU Karsten Golf Course, 1125 East ...
... work, researchers say , SUNDAY, Feb. 14 (HealthDay News) -- ... here,s good news. , Office romances don,t bother fellow workers ... finds. , "Most people believe romantic relationships [at work] are ... colleagues or have an impact on the overall work environment," ...
... ... affordable 100% natural latex mattress or 100% natural latex topper. Mattress covers are made ... mattress, free from chemical fire-retardants. , ... (PRWEB) February 14, 2010 -- Foamsource has added the Natural Slumber ...
Cached Medicine News:Health News:Kardea Nutrition Adds V.P. Sales, Extends Distribution Network 2Health News:U.S. Census Bureau Daily Feature for Feb. 15 2Health News:Medicare data reveals differences in orthopedic surgical outcomes 2Health News:Businesses Rally Big Efforts to Benefit the Susan G. Komen Phoenix Affiliates' Fight Against Breast Cancer 2Health News:Businesses Rally Big Efforts to Benefit the Susan G. Komen Phoenix Affiliates' Fight Against Breast Cancer 3Health News:Office Romance OK With Most Folks 2Health News:Foamsource Introduces Natural Slumber 100% Natural Latex Mattresses & Toppers with Free Shipping 2Health News:Foamsource Introduces Natural Slumber 100% Natural Latex Mattresses & Toppers with Free Shipping 3
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
Medicine Products: