Navigation Links
FDA Approves ZYFLO CR(TM) (Zileuton) for Chronic Treatment of Asthma

Dey, L.P. announced today that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) of its marketing partner, Critical Therapeutics, Inc., for ZYFLO CR(TM) (zileuton) extended-release tablets. ZYFLO CR(TM) offers twice-daily, extended-release dosing. Under a co-promotion agreement executed between the two companies in March 2007, DEY will co-market Critical Therapeutics' ZYFLO CR(TM).

ZYFLO CR(TM) and ZYFLO(R) (zileuton tablets) are the only FDA-approved leukotriene synthesis inhibitors for the prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older. ZYFLO CR(TM) and ZYFLO(R) are not indicated for use in the reversal of bronchospasm in acute asthma attacks, but can be continued during acute exacerbations of asthma. Leukotrienes are inflammatory mediators in asthma that can trigger asthma symptoms, including inflammation, swelling, bronchoconstriction and mucus secretion. ZYFLO CR(TM) uses SkyePharma PLC's (LSE: SKP) proprietary Geomatrix(R) drug delivery technology, which controls the amount and rate of drug released into the body.

"We applaud our marketing partner's success in securing FDA approval of the only twice-daily leukotriene synthesis inhibitor for asthma," said Mel Engle, President and CEO of DEY. "ZYFLO CR(TM) has a unique mechanism of action that, combined with its twice-daily dosing regimen, could fundamentally expand and improve the treatment options available to asthma patients. We are delighted to participate in commercializing Critical Therapeutics' ZYFLO CR(TM), which will continue to expand DEY's presence in asthma and respiratory care."

In March 2007, Critical Therapeutics and DEY entered into an agreement for the co-promotion of ZYFLO CR(TM) and ZYFLO(R), the immediate-release formulation of zileuton. DEY's sales force began promoting ZYFLO(R) on April 30, 2007. Upon the launch of ZYFLO CR(TM), the combined sales forces of the two
'"/>




Page: 1 2

Related medicine news :

1. FDA Approves Contraceptive Ring
2. FDA Approves New HIV Drug, Viread
3. FDA Approves Birth Control Skin Patch
4. FDA Approves New Arthritis Drug, Bextra
5. FDA Approves Elidel Cream for Eczema
6. FDA Approves New Anti-Clotting Drug
7. FDA Approves New surgery Treatment for Farsightedness
8. FDA Approves Anti-Cancer Cell Drug - Zevalin
9. FDA Approves Remodulin for Pulmonary Hypertension
10. World Health Organisation Takes a Historic Decision and Approves Treaty to Discourage Smoking
11. World Health Organisation Takes a Historic Decision and Approves Treaty to Discourage Smoking
Post Your Comments:
*Name:
*Comment:
*Email:
TAG: FDA Approves ZYFLO Zileuton for Chronic Treatment Asthma

(Date:10/2/2014)... Dennis Thompson HealthDay Reporter ... of developing celiac disease isn,t reduced by breast-feeding. Nor will ... gluten to an infant,s diet help prevent celiac disease. ... studies in the Oct. 2 New England Journal of ... that a child could avoid celiac disease if mothers breast-feed ...
(Date:10/1/2014)... researchers from the University of Adelaide have developed a ... of a good outcome from treatment - from their ... on a range of factors, including clinical symptoms, cognitive ... in the patient,s blood. , Speaking in the lead ... University,s Head of Psychiatry , Professor Bernhard ...
(Date:10/1/2014)... research co-funded by the Engineering and Physical Sciences ... of the UK,s vital industrial control systems which ... electricity grid, and the rail network. , ... from hackers or malware infiltrating the systems behind ... Institute in Trustworthy Industrial Control Systems (RITICS), based ...
(Date:10/1/2014)... Marriagelifeinsurance.com has released a new blog ... couples. , Senior citizens can purchase a joint ... loved ones. A joint policy is cheaper, but will ... , Life insurance can be used to cover ... be purchased online, as the application process is simple ...
(Date:10/1/2014)... 01, 2014 Phoseon Technology, the pioneer ... to expand the business worldwide. This rapid growth includes ... capacity for manufacturing efforts. The company has experienced average ... years and expects this growth to continue in the ... gains worldwide adoption. , “We are very pleased ...
Breaking Medicine News(10 mins):Health News:Infant's Early Diet Doesn't Change Celiac Disease Risk, Study Finds 2Health News:Infant's Early Diet Doesn't Change Celiac Disease Risk, Study Finds 3Health News:Predicting the future course of psychotic illness 2Health News:£2.5 million to recognize and reduce cyber-attack threats to critical infrastructure 2Health News:Elderly Life Insurance - Find Life Insurance for Retired Couples! 2Health News:Phoseon Technology Continues to Drive Growth Worldwide 2
... , , TAMPA, Fla. ... Solutions, today announced the appointment of Michael Unhjem as a member of ... (Logo: http://www.newscom.com/cgi-bin/prnh/20090709/FL43703LOGO ) , ... of Blue Cross Blue Shield (BCBS) of North Dakota, was unanimously elected ...
... SEATTLE, July 20 Group Health Cooperative medical centers received ... the Puget Sound Health Alliance Community Checkup . Group ... nine medical groups in the Puget Sound region that were rated on ... regional average" scores. , , "We support ...
... , MINNEAPOLIS, July 20 ... into a business relationship with Cardiocom(R) to provide advanced home ... Experts in Telehealth(SM), is a world class developer, manufacturer and ... , Cardiocom,s telehealth system provides an interactive ...
... 20 N y comed tod a y announced t h e su b mission of a N e ... n d Drug Administr a tion ( F DA) for ... oral treatme n t for patie n t s ... i ssion is ba s e d on enc ou raging result s fro m ...
... , , ... DIEGO, July 20 Orexigen(R) Therapeutics, Inc. (Nasdaq: OREX ) today ... its investigational drug for the treatment of obesity, met their co-primary endpoints. ... O besity R esearch, or COR, program of more ...
... , , ... -- Allscripts (Nasdaq: MDRX ) announced today ... Human Resources. Ms. Adams brings to the position more than 20 ... high tech industry, most recently as Vice President of Human Resources ...
Cached Medicine News:Health News:Michael Unhjem Appointed to Board of Directors for Health Integrated 2Health News:Michael Unhjem Appointed to Board of Directors for Health Integrated 3Health News:Group Health Cooperative Scored Above Regional Average in 11 of 15 Quality Measures 2Health News:Silas Home Care Selects Cardiocom Telehealth Technology 2Health News:Nycomed Announces FDA Filing for Daxas(R) in COPD 2Health News:Nycomed Announces FDA Filing for Daxas(R) in COPD 3Health News:-Contrave(R) Obesity Research Phase 3 Program Meets Co-Primary and Key Secondary Endpoints; Exceeds FDA Efficacy Benchmark for Obesity Treatments- 2Health News:-Contrave(R) Obesity Research Phase 3 Program Meets Co-Primary and Key Secondary Endpoints; Exceeds FDA Efficacy Benchmark for Obesity Treatments- 3Health News:-Contrave(R) Obesity Research Phase 3 Program Meets Co-Primary and Key Secondary Endpoints; Exceeds FDA Efficacy Benchmark for Obesity Treatments- 4Health News:-Contrave(R) Obesity Research Phase 3 Program Meets Co-Primary and Key Secondary Endpoints; Exceeds FDA Efficacy Benchmark for Obesity Treatments- 5Health News:-Contrave(R) Obesity Research Phase 3 Program Meets Co-Primary and Key Secondary Endpoints; Exceeds FDA Efficacy Benchmark for Obesity Treatments- 6Health News:-Contrave(R) Obesity Research Phase 3 Program Meets Co-Primary and Key Secondary Endpoints; Exceeds FDA Efficacy Benchmark for Obesity Treatments- 7Health News:-Contrave(R) Obesity Research Phase 3 Program Meets Co-Primary and Key Secondary Endpoints; Exceeds FDA Efficacy Benchmark for Obesity Treatments- 8Health News:-Contrave(R) Obesity Research Phase 3 Program Meets Co-Primary and Key Secondary Endpoints; Exceeds FDA Efficacy Benchmark for Obesity Treatments- 9Health News:Diane Adams Joins Allscripts as Executive Vice President, Human Resources 2Health News:Diane Adams Joins Allscripts as Executive Vice President, Human Resources 3Health News:Diane Adams Joins Allscripts as Executive Vice President, Human Resources 4
(Date:10/1/2014)... 1, 2014  SI-BONE, Inc., a medical device company that ... a minimally invasive surgical (MIS) device indicated for fusion for ... expansion of its European operations with the formation of a ... as General Manager, Germany.  Mr. Schaber will join former Kyphon ... Europe , Middle East ...
(Date:10/1/2014)... Oct. 1, 2014  CVS Health is thanking its ... role in changing the way health care is delivered ... the Company,s retail pharmacies, mail service pharmacies and specialty ... our company name to CVS Health to reflect our ... the innovations needed to shape the future of health," ...
(Date:10/1/2014)... Switzerland , October 1, 2014 ... Genomics and Next Generation Sequencing (NGS) data analysis, today ... run full cystic fibrosis analysis in a single NGS ... characterisation of all types of variants in a single ... Until now, it has not been possible to simultaneously ...
Breaking Medicine Technology:SI-BONE, Inc. Announces European Expansion with Appointment of Eric Schaber as General Manager, Germany and Formation of GmbH 2SI-BONE, Inc. Announces European Expansion with Appointment of Eric Schaber as General Manager, Germany and Formation of GmbH 3SI-BONE, Inc. Announces European Expansion with Appointment of Eric Schaber as General Manager, Germany and Formation of GmbH 4CVS Health Thanking its Pharmacists during American Pharmacists Month for Helping People on Their Path to Better Health 2CVS Health Thanking its Pharmacists during American Pharmacists Month for Helping People on Their Path to Better Health 3Sophia Genetics Launches Full CFTR Analysis in Single Clinical Grade NGS Experiment 2
... and JERUSALEM, Sept. 14, 2011 Chiasma, Inc., a privately ... CEO, will present an overview of the Company at the ... York, New York, on Monday, September 19, 2011 at 1:30 ... oral form of octreotide acetate being developed first for the ...
... Medical Technologies, Inc. and the Physician Services technology ... announced an agreement for INHS to provide Greenway,s ... solution PrimeSUITE® 2011 to hospital systems ... network interoperability. Established more than a ...
Cached Medicine Technology:Chiasma to Present at the UBS Global Life Sciences Conference 2Greenway Partners With INHS to Advance EHR Adoption 2Greenway Partners With INHS to Advance EHR Adoption 3
... PACHETT 3 uses the exact enhanced corneal ... DGH pachymeters used exclusively by the OHTS ... into the software. The new backlit LCD ... average, standard deviation and IOP correction calculation ...
The Medmont C100 Colour Vision Tester is an electronic colour vision screening device which is used to rapidly detect red/green colour vision deficiencies. Its high sensitivity provides a positive in...
... E300 Corneal Topographer has applications ... clinical procedures including Radial Keratotomy, ... Contact Lens Fitting. Based on ... the E300 analyses an accurate ...
... first Open Bore MR ,Siemens has combined, for ... bore, a very short 125 cm magnet and ... very revolutionary: Open Bore MR. And MAGNETOM Espree, ... A unique Siemens technology, which means faster, more ...
Medicine Products: