Navigation Links
Horizon Pharma, Inc. Announces FDA Acceptance of DUEXA(R) New Drug Application for Filing
Date:5/26/2010

NORTHBROOK, Ill., May 26 /PRNewswire/ -- Horizon Pharma, Inc., a late-stage biopharmaceutical company focused on the development and commercialization of innovative medicines for pain-related diseases and inflammation, today announced that its New Drug Application (NDA) for DUEXA®, a proprietary tablet formulation containing a fixed-dose combination of ibuprofen and high-dose famotidine, was accepted by the U.S. Food and Drug Administration (FDA) for review.  Horizon is seeking FDA approval of DUEXA for the reduction of the risk of development of upper gastrointestinal ulcers in patients with arthritis and pain.  The PDUFA date for completion of the FDA's review for DUEXA is expected in the first quarter of 2011.

"As the pain and arthritis market continues to grow, safe and effective treatments are desperately needed for physicians and patients concerned about the gastrointestinal impact of NSAIDs," said Timothy P. Walbert, chairman, president and chief executive officer of Horizon Pharma.  "We look forward to working closely with the FDA to bring DUEXA to market as quickly as possible.  The filing of the DUEXA NDA brings us one step closer to providing the millions suffering from mild-to-moderate pain and arthritis with a new treatment option."

The DUEXA NDA submission was based on two Phase 3 clinical studies (REDUCE-1 and REDUCE-2), which demonstrated that patients with mild-to-moderate pain treated with DUEXA developed approximately fifty percent less upper gastrointestinal (GI) ulcers) compared to patients treated with ibuprofen alone.   The trials were conducted in the U.S. via a Special Protocol Assessment (SPA) with the FDA and enrolled more than 1,500 patients.  Based on these data, the Company also plans to submit a marketing authorization appl
'/>"/>

SOURCE Horizon Pharma, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. Horizon Therapeutics Presents Phase 3 Study Results Identifying Risk Factors for Ulcer Development Among NSAID Users
2. Horizon Therapeutics HZT-501 Significantly Reduces Incidence of NSAID-Induced Upper Gastrointestinal Ulcers in Patients With Mild-to-Moderate Pain
3. Boston Scientific Welcomes Publication of HORIZONS AMI Trial Results in New England Journal of Medicine
4. Horizon Therapeutics Announces Two Pivotal HZT-501 Phase 3 Trials Meet Primary Endpoints
5. HORIZONS AMI Trial Demonstrates Superior Outcomes with TAXUS(R) Drug-Eluting Stents in Heart Attack Patients
6. Horizon Therapeutics Completes Enrollment in Phase 3 Trials for Lead Product Candidate HZT-501
7. GlaxoSmithKline and Theravance Announce Start of Large Phase 2B ICS and LABA Studies for Asthma in the Horizon Program
8. Horizon Therapeutics Initiates Long-Term Phase 3 Safety Study for Lead Product Candidate HZT-501
9. SCOLR Pharma, Inc. Enters into Worldwide Licensing Agreement with RedHill Biopharma Ltd.
10. Pangu BioPharma, aTyr Pharmas Subsidiary in Hong Kong, Receives New Research Grant From Hong Kong Innovation and Technology Commission
11. Berger & Montague, P.C., Files Class Action Against Hemispherx Biopharma, Inc. Extending the End of the Class Period to December 1, 2009, When the Company Announced That the FDA Found No Evidence of Efficacy of Its Drug
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/14/2014)... Jan. 14, 2014  Luminex Corporation (Nasdaq: LMNX ) ... fourth quarter of 2013 on Monday, February 3, 2014. A ... the close of trading. (Logo: http://photos.prnewswire.com/prnh/20100104/LUMINEXLOGO ... discuss the operating highlights and financial results for the fourth ...
(Date:1/14/2014)... , Jan. 14, 2014 /PRNewswire-iReach/ -- Acumed,s new SLIC ... guide with accompanying instrumentation to place and insert the ... the soft tissue (e.g. ligament) repair or reconstruction as ... heals. (Photo: http://photos.prnewswire.com/prnh/20140114/MN45636 ) ...
(Date:1/14/2014)... 2014   Oligomerix, Inc. , a privately held company ... disease (AD) and related neurodegenerative disorders, announced today the ... NY as of January 15, 2014 and ... York Medical College. Oligomerix, which is focused ...
Breaking Medicine Technology:Luminex Corporation Fourth Quarter Earnings Release Scheduled for February 3, 2014 2Luminex Corporation Fourth Quarter Earnings Release Scheduled for February 3, 2014 3Acumed introduces the Scapho-Lunate Inter Carpal (SLIC) Screw System 2Acumed introduces the Scapho-Lunate Inter Carpal (SLIC) Screw System 3Oligomerix Relocates Corporate Headquarters and Secures Additional Laboratory Space from New York Medical College 2
... Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN ), Eli ... Inc. (Nasdaq: ALKS ) today announced that the ... response letter regarding the New Drug Application (NDA) for BYDUREON™ ... complete response letter the FDA requested a thorough QT (tQT) ...
... , Matt Perkins, chief technology officer and senior vice ... provider of ZigBee-based real-time location solutions ( RTLS ) ... real-time location and condition sensing and ZigBee -based ... and beyond at the 2010 Mobile Health Expo.  WHAT: ...
Cached Medicine Technology:Amylin, Lilly and Alkermes Announce Receipt of Complete Response Letter from FDA for BYDUREON™ 2Amylin, Lilly and Alkermes Announce Receipt of Complete Response Letter from FDA for BYDUREON™ 3Amylin, Lilly and Alkermes Announce Receipt of Complete Response Letter from FDA for BYDUREON™ 4Amylin, Lilly and Alkermes Announce Receipt of Complete Response Letter from FDA for BYDUREON™ 5Amylin, Lilly and Alkermes Announce Receipt of Complete Response Letter from FDA for BYDUREON™ 6Amylin, Lilly and Alkermes Announce Receipt of Complete Response Letter from FDA for BYDUREON™ 7Awarepoint to Present 'ZigBee-based Wireless Sensor Networks for Use in Acute Care Hospitals and Beyond' at Mobile Health Expo Speaker Session 2Awarepoint to Present 'ZigBee-based Wireless Sensor Networks for Use in Acute Care Hospitals and Beyond' at Mobile Health Expo Speaker Session 3
(Date:4/17/2014)... Council scientists and their partners have found that their ... the transmission of multiple sexually transmitted infections (STIs) in ... simplex virus 2 (HSV-2), and human papillomavirus (HPV). The ... gel is effective against multiple strains of HIV, and ... all three viruses of at least eight hours prior ...
(Date:4/17/2014)... and alleviates muscle soreness after exercise, according to ... Illinois at Chicago. , The study, reported online ... of Physical Medicine and Rehabilitation , also showed ... had not exercised, suggesting that massage has benefits ... activity. , Improved circulation and relief of muscle ...
(Date:4/17/2014)... 94 per cent of Canadians surveyed said they would ... a specific number of genetic conditions, only 80 per ... screening that would sequence their newborns, genomes.,Most newborns in ... first day or two of life in which a ... and tested for about five to 54 conditions, depending ...
(Date:4/17/2014)... its status as the leading weapon against the deadly ... with new research indicating it simply needs to be ... of the cheap anti-malarial drug chloroquine in treating and ... more than half a million people each year around ... developed resistance to chloroquine, but research carried out at ...
(Date:4/16/2014)... , PHOENIX, Ariz. April 15, 2014 The ... Arizona philanthropists at their annual Founders Dinner for their ... cancer. The event took place March 28 in Scottsdale. ... & Catherine Ivy Foundation, received TGen,s John S. McCain ...
Breaking Medicine News(10 mins):Health News:Animal study provides first evidence that gel can prevent multiple virus transmission in vagina/rectum 2Health News:Massage therapy improves circulation, eases muscle soreness 2Health News:Researcher looks at public perceptions around newborn testing 2Health News:Researcher looks at public perceptions around newborn testing 3Health News:Scientists find new way to fight malaria drug resistance 2Health News:TGen honors Catherine Ivy and Craig Jackson with Leadership; Collaborative Spirit awards 2
... work better in protecting children from flu if they included ... Louis University research has found. "Adding a second influenza ... some of the guesswork out of strain selection and help ... M.D., lead investigator and director of the Center for Vaccine ...
... ... Wigix Inc.’s subsidiary, ddku.com, affording it an end to end marketing platform in China. ... Oakland, CA ... has acquired a Shanghai-based business process outsourcing company, Mag2U, to enhance DDKU’s growing internet ...
... diagnosis should consider genetic testing, experts say , TUESDAY, April ... age 55 who also have a genetic mutation that boosts ... cancer in the opposite breast than are women who don,t ... Risk increased fourfold for these women, who carry a mutation ...
... (Baltimore, MD) Today, the Interactive Autism Network ... project, announces results of the Grandparents of Children ... one-third of grandparents who participated were the first ... its launch in 2007, the IAN Project has ...
... April, 2010 The global nursing shortage is due in ... to a phenomenon known as nurse migration, where nurses leave ... International Council of Nurses (ICN) and the Honor Society of ... Foundation, will conduct the Global Summit on Nurse Faculty Migrationa ...
... Attention-deficit/hyperactivity disorder (ADHD) is one of the most common ... ADHD are excessively restless, impulsive, and distractible and experience ... are a common theme for ADHD symptoms. These ... or a combination of the two. In ...
Cached Medicine News:Health News:Building a better flu vaccine: Add second strain of influenza B 2Health News:Wigix Acquires Mag2U, A Leading Business Process Outsourcing Company 2Health News:Wigix Acquires Mag2U, A Leading Business Process Outsourcing Company 3Health News:Gene Mutations Up Risk for Cancer in Opposite Breast 2Health News:Gene Mutations Up Risk for Cancer in Opposite Breast 3Health News:New survey finds grandparents play key role in lives of children with autism 2Health News:New survey finds grandparents play key role in lives of children with autism 3Health News:International summit seeks solutions to global shortage of nursing faculty 2Health News:Synergy between behavioral and pharmacologic interventions for ADHD 2
... single-lead principle has been applied to cardiac resynchronization ... which consists of the Tupos LV/A+ and the ... surgery and the risk of complications. The ICD ... via a single lead. The atrial input stage ...
... ICD cardiac resynchronization and ICD device offers ... The unit's RV only sensing provides no ... LV depolarizations, eliminating this cause of inappropriate ... LV separation for optimized hemodynamics. Proven PR ...
... The Medtronic InSync II Marquis ... and ICD therapy. Cardiac resynchronization benefits ... adapt pacing outputs to unique patient ... monitoring functions that help physicians manage ...
... Guidant's Contak Renewal 2 cardiac resynchronization ... therapy for the treatment of heart ... the right and left ventricles or ... contractions. The device provides ventricular tachyarrhythmia ...
Medicine Products: