Navigation Links
Xanodyne Receives Approval From the U.S. Food and Drug Administration for ZIPSOR(TM) (diclofenac potassium) Liquid Filled Capsules
Date:6/17/2009

NEWPORT, Ky., June 17 /PRNewswire/ -- Xanodyne Pharmaceuticals, Inc. announced today that it has received approval from the U.S. Food and Drug Administration (FDA) for Zipsor (diclofenac potassium) Liquid Filled Capsules, a new treatment option indicated for relief of mild to moderate acute pain in adults (18 years of age or older).

"Zipsor is a drug with several unique features," said Gary A. Shangold, Chief Medical Officer of Xanodyne. "It is the first NSAID to be approved based on the demonstration of safety and efficacy in two well controlled post-surgical bunionectomy clinical trials and accomplished this with the lowest available dose (25 mg) of any currently marketed diclofenac potassium product in the United States. It will also be the first and only prescription strength NSAID for oral administration available for the U.S. market in a liquid-filled soft gelatin capsule," continued Dr. Shangold.

The low recommended total daily dose of diclofenac potassium delivered with Zipsor aligns with current guidance from the FDA recommending utilization of NSAIDs at the lowest effective dose, for the shortest amount of time. Zipsor was generally well-tolerated and demonstrated efficacy in two multiple dose post-surgery (bunionectomy) clinical trials. At baseline, Zipsor patients had an average pain intensity of 6.9 (on a 0 to 10 numeric pain rating scale).

"Demonstrating efficacy at a low dose not previously available to the market presents an important new therapeutic option to the physician and a significant opportunity for Xanodyne. It is also a significant milestone for our company as Zipsor represents the first approval to come out of our R&D organization. We are completing our launch preparations and our expectation is to have Zipsor on the US market within the coming months," said Michael Valentino, President and Chief Executive Officer.

Important Safety Information about
'/>"/>

SOURCE Xanodyne Pharmaceuticals, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2

Related medicine news :

1. Xanodyne Announces Appointment of Mr. Vaughn M. Kailian of MPM Capital to the Board of Directors
2. Xanodyne Announces New President/CEO and Completes $38 Million Equity Financing
3. Xanodynes New Drug Application for the Treatment of Heavy Menstrual Bleeding (Menorrhagia) Accepted for Filing with a Priority Review Classification
4. Epeius Biotechnologies Rexin-G Receives FDA Fast Track Designation for the Treatment of Pancreatic Cancer
5. STAAR Surgical Receives Japanese Clearance for the KS-Ni Preloaded IOL Injector System
6. Herzing University, Minneapolis Receives Board of Nursing Approval
7. Steelcase Inc. Receives Five Best of NeoCon Awards and Best Overall Showroom for Nurture at NeoCon 2009
8. President Obama Receives Warm Welcome from AMA Physicians
9. Biomerix Corporation Receives ISO 13485 Certification
10. Instrumentation Laboratory Receives 510(k) Clearance From FDA for HemosIL(R) Liquid Heparin Assay
11. Endologix Receives Nasdaq Letter on Director Independence
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/1/2014)... “When insulation goes bad,” Clean Crawls says, “It ... newly released article entitled, “ 5 Signs That Your ... ,” Clean Crawls explains the need to replace insulation ... critters. , Get a free attic insulation or ... http://www.cleancrawl.com/contact . , If crawl space or attic insulation ...
(Date:8/1/2014)... 2014 Over 20,000 entrepreneurs from around ... 2014 Market America | SHOP.COM International Convention at the ... annual event will introduce new products, technology, programs and ... and also feature a who’s who of celebrities. ... SHOP.COM Executive Team, successful entrepreneurs and celebrity guests. Previous ...
(Date:8/1/2014)... CA (PRWEB) August 01, 2014 ... advancing gynecologic endoscopic surgery, is pleased to announce ... in the United States and Europe, which strongly ... available to surgeons an endoscopic dry lab for ... of their endoscopic surgery skills. , Endoscopy is ...
(Date:8/1/2014)... 01, 2014 Stress management can be difficult ... hours of concentration and diminish rest and leisure time, stress ... is critical to find a way to manage stress in ... life. , “Having a good sense of work-life balance is ... Jacobs, founding clinician of SF Custom Chiropractic. “Stress, left ...
(Date:7/31/2014)... July 31, 2014 The 2013 ... developments about chemical listings, appellate decisions, litigation and ... may affect compliance with California's Proposition 65. , ... the law, regulations, history and trends impacting California's ... fourth installment of the series which adds approximately ...
Breaking Medicine News(10 mins):Health News:5 Signs That Insulation Should Be Replaced Detailed in a Newly Released Article By Clean Crawls 2Health News:Market America | SHOP.COM Set to Unveil Technology Enhancements and New Products at the 2014 International Convention 2Health News:Market America | SHOP.COM Set to Unveil Technology Enhancements and New Products at the 2014 International Convention 3Health News:Market America | SHOP.COM Set to Unveil Technology Enhancements and New Products at the 2014 International Convention 4Health News:Market America | SHOP.COM Set to Unveil Technology Enhancements and New Products at the 2014 International Convention 5Health News:AAGL Announces It Has Joined With Other Medical Societies to Encourage Hospitals Teaching Endoscopic Surgery to Establish Simulator Labs for Training 2Health News:SF Custom Chiropractic Celebrates National Relaxation Day and the Benefits of Massage Therapy for the Month of August 2Health News:Save 25% on the Proposition 65 Handbook - 2013 Edition Through August 31 2
... marketing is a missed opportunity for states to improve ... alcohol advertising laws from the Center on Alcohol Marketing ... of Public Health. The report examines the ... different best practices to reduce youth exposure to alcohol ...
... of an important clinical trial on age-related macular degeneration ... (or CATT), were published in the journal Ophthalmology ... Avastin (bevacizumab) and Lucentis (ranibizumab), commonly used to treat ... maintaining vision. In this clinical trial ...
... -- A management plan to gather, assess and respond to ... approved until they are no longer on the market is ... an Institute of Medicine report released Tuesday. The U.S. ... trial evidence that their benefits outweigh their risks. However, the ...
... MONDAY, April 30 (HealthDay News) -- A new analysis ... says those with a family history of breast cancer or ... The benefits of getting a mammogram every two years ... increased risk for developing breast cancer, according to the U.S. ...
... 1 (HealthDay News) -- Taser guns used by law enforcement ... according to a new study. Tasers, which are widely ... countries, are designed to stun suspects by delivering a 50,000-volt ... analyzed the cases of eight healthy men, ages 16 to ...
... for ordering chest CT examinations translates into positive examinations ... The study, conducted at Massachusetts General Hospital in Boston, ... of a decision support system, found that 76% of ... , "Rising concerns about radiation risks, imaging growth and ...
Cached Medicine News:Health News:Majority of states fail to address youth exposure to alcohol marketing 2Health News:Interpreting the Avastin-Lucentis study for persons with macular degeneration 2Health News:Interpreting the Avastin-Lucentis study for persons with macular degeneration 3Health News:Better Ways Needed to Track Drug Safety: Report 2Health News:Better Ways Needed to Track Drug Safety: Report 3Health News:Here Are the Women Who Need Mammograms in Their 40s: Study 2Health News:Here Are the Women Who Need Mammograms in Their 40s: Study 3
(Date:7/31/2014)... Calif., July 31, 2014 Pharmacyclics, Inc. (the "Company") ... recent developments for the quarter ended June 30, 2014. ... June 30, 2014 Revenue Total revenue for the quarter ... million for the quarter ended June 30, 2013 primarily due ... million. Total revenue for the six months ...
(Date:7/31/2014)... , July 31, 2014   Auxilium Pharmaceuticals , ... specialty biopharmaceutical company, today announced that the Company will ... Thursday, August 7, 2014 before the opening of the ... conference call that day at 8:30 a.m. ET to ... 2014. The presentation slides to be used during the ...
(Date:7/31/2014)... -- Decision Resources Group is launching an extension of its ... include ChinaTrack; the new capabilities track the ... providing detailed brand-level share tracking and analytics. ChinaTrack also ... Other key capabilities of the new line extension: ... end-user surveys of healthcare facilities, ChinaTrack data is paired ...
Breaking Medicine Technology:Pharmacyclics Reports Second Quarter 2014 Results 2Pharmacyclics Reports Second Quarter 2014 Results 3Pharmacyclics Reports Second Quarter 2014 Results 4Pharmacyclics Reports Second Quarter 2014 Results 5Pharmacyclics Reports Second Quarter 2014 Results 6Pharmacyclics Reports Second Quarter 2014 Results 7Pharmacyclics Reports Second Quarter 2014 Results 8Pharmacyclics Reports Second Quarter 2014 Results 9Pharmacyclics Reports Second Quarter 2014 Results 10Pharmacyclics Reports Second Quarter 2014 Results 11Pharmacyclics Reports Second Quarter 2014 Results 12Pharmacyclics Reports Second Quarter 2014 Results 13Pharmacyclics Reports Second Quarter 2014 Results 14Pharmacyclics Reports Second Quarter 2014 Results 15Pharmacyclics Reports Second Quarter 2014 Results 16Pharmacyclics Reports Second Quarter 2014 Results 17Pharmacyclics Reports Second Quarter 2014 Results 18Pharmacyclics Reports Second Quarter 2014 Results 19Pharmacyclics Reports Second Quarter 2014 Results 20Pharmacyclics Reports Second Quarter 2014 Results 21Pharmacyclics Reports Second Quarter 2014 Results 22Pharmacyclics Reports Second Quarter 2014 Results 23Pharmacyclics Reports Second Quarter 2014 Results 24Pharmacyclics Reports Second Quarter 2014 Results 25Pharmacyclics Reports Second Quarter 2014 Results 26Pharmacyclics Reports Second Quarter 2014 Results 27Pharmacyclics Reports Second Quarter 2014 Results 28Auxilium Pharmaceuticals, Inc. To Announce Second Quarter 2014 Results On August 7, 2014 2Auxilium Pharmaceuticals, Inc. To Announce Second Quarter 2014 Results On August 7, 2014 3Decision Resources Group Announces First Medical Device Account Targeting Tool in China 2
Smartepil II is a laser particularly indicated for hair-removal where it has proved to be a valid instrument, even in the treatment of darker phototypes and telangiectasias of the face and legs....
... Tri-Active is the result of ... the combination of three different methods ... to your skin. This treatment is ... of cellulite through the combined action ...
... is a CO2 laser system with ... Its functions in continuous and super-pulsed ... extreme laser intervention delicacy. Excellent as ... it comes with a large LCD ...
... professional digital imaging system for ophthalmology and ... to acquire, analyze, and store your patient ... use the most are,available right on the ... easily. This high-resolution system supports images captured ...
Medicine Products: