Navigation Links
Eurand's Zentase Effective in Treating Exocrine Pancreatic,Insufficiency, Studies Show

.S. Federal Food, Drug and Cosmetic Act in 1938 and consequently none of the currently available products are marketed under a NDA approved by the FDA. In April, 2004, the FDA mandated that all manufacturers of EPI drug products file a NDA and receive approval for their products by April 2008 or be subject to regulatory action.

One of the FDA requirements to submit an NDA for a PEP is the elimination of product overfill allowed under current guidelines. Currently, individual enzyme doses can be overfilled up to 165 percent of label claim(3) to compensate for the breakdown of enzymes over time and to ensure that each capsule contains at least 90 percent of the label claim at the end of the product's shelf life. As a result, patients taking PEPs may be unknowingly over or under treating their disease by using a product with variable potency. This variability can put patients at risk for colonic strictures with overtreatment or malnutrition with undertreatment.

As a highly-stable product, Zentase does not require overfill. It will be filled at 100 percent of label claim, with a minimum of 2-years shelf life, to ensure consistent dosage and maintain treatment levels over time.

About Eurand

Eurand is a specialty pharmaceutical company that develops enhanced pharmaceutical and biopharmaceutical products based on its proprietary drug formulation technologies. Eurand has had four products approved by the FDA since 2000 and has a pipeline of product candidates in development for itself and its collaboration partners. Eurand's technology platforms include bioavailability enhancement of poorly soluble drugs, customized release, taste-making/fast-dissolving formulations and drug conjugation.

Eurand is a global company with facilities in the USA and Europe. For more information, visit Eurand's website at www.eurand.com.

This release, and oral statements made with respect to informatio
'"/>




Page: 1 2 3 4 5 6 7 8

Related medicine technology :

1. Eurand to Present Zentase Phase III Data
2. New Study Shows That Extending Prophylaxis With Clexane / Lovenox (enoxaparin Sodium Injection) to 5 Weeks is More Effective Than 10 Days for Reducing the Risk of Venous Thromboembolism (VTE) in Acutely ill Medical Patients With Reduced Mobility
3. Cimzia Effective in Reducing Signs and Symptoms of Rheumatoid Arthritis
4. Gabapentin Shown Effective for Fibromyalgia Pain
5. ApoCells Cancer Predictive Index Helps Oncologists Select the Most Effective Targeted Drug Therapy
6. Roxro Pharma’s Novel Intranasal Pain Reliever Effective, Well Tolerated in Phase 3 Study
7. XYOTAX More Cost Effective With Fewer Side Effects Than Gemcitabine or Vinorelbine in Treating Non-Small Cell Lung Cancer
8. Soliris Effective in PNH Patients With History of Aplastic Anemia and Myelodysplastic Syndromes
9. Repeated Radioimmunotherapy With 131I-Labetuzumab Appears Safe and Effective in Colorectal Cancer with Liver Metastases
10. Biotheras Imprime PGG Enhanced Effectiveness of Avastin in Cancer Study
11. Targanta Study Shows Oritavancin Treatment Effective in a Mouse Model of Anthrax
Post Your Comments:
(Date:8/27/2015)... 27, 2015 According to a ... Type (Integrated, Standalone), by Deployment Mode (Web based, On-Premise, ... Healthcare Service Providers), by Component - Global Trends & ... is estimated at $501.1 Million 2014, and is projected ... of 7.6% from 2014 to 2019. ...
(Date:8/27/2015)... 2015  Mytrus, a technology and services company revolutionizing clinical trials, ... consent has received approval for use by ... the first time e-Consent technology will be used in ... Mytrus was also the first electronic informed ... by the U.S. Food and Drug Administration in 2011. ...
(Date:8/27/2015)... Colo. , Aug. 27, 2015  Lightwave ... on the development of Next Generation Photonic ... for applications in high speed fiber-optic data communications ... Michael Lebby has been appointed to the ... reputation in the field of optoelectronics is widely ...
Breaking Medicine Technology:Radiology Information Systems Market Worth $722.7 Million by 2019 2Radiology Information Systems Market Worth $722.7 Million by 2019 3Radiology Information Systems Market Worth $722.7 Million by 2019 4Britain's National Health Service Approves The Use Of Mytrus Technology For Electronic Informed Consent In Clinical Trials 2Britain's National Health Service Approves The Use Of Mytrus Technology For Electronic Informed Consent In Clinical Trials 3Britain's National Health Service Approves The Use Of Mytrus Technology For Electronic Informed Consent In Clinical Trials 4Britain's National Health Service Approves The Use Of Mytrus Technology For Electronic Informed Consent In Clinical Trials 5Britain's National Health Service Approves The Use Of Mytrus Technology For Electronic Informed Consent In Clinical Trials 6Britain's National Health Service Approves The Use Of Mytrus Technology For Electronic Informed Consent In Clinical Trials 7Lightwave Logic Announces the Appointment of Optoelectronics Industry Leader, Michael Lebby, Ph.D. to its Board of Directors 2Lightwave Logic Announces the Appointment of Optoelectronics Industry Leader, Michael Lebby, Ph.D. to its Board of Directors 3
... 2011 With the support of Key Opinion Leaders ... the time and attention of KOLs is intensifying. But ... landscape for creating and maintaining KOL and physician relationships. ... KOL landscape, Best Practices, LLC has published an updated ...
... Endo Pharmaceuticals (Nasdaq: ENDP ) announced today ... of President, HealthTronics Inc., effective Aug. 29, 2011. HealthTronics, ... urological products and services based in Austin, Texas. ... HealthTronics Group President James Whittenburg, who is staying through ...
Cached Medicine Technology:Pharma Medical Science Liaison Outreach Shifting Away from Traditional Company Sales Regions 2Endo Pharmaceuticals Announces Leadership Change at HealthTronics Subsidiary: Appoints Kelly Huang, Ph.D. New President 2Endo Pharmaceuticals Announces Leadership Change at HealthTronics Subsidiary: Appoints Kelly Huang, Ph.D. New President 3
(Date:8/28/2015)... Texas (PRWEB) , ... August 28, 2015 , ... Yisrayl ... a new publication and pleads for swift actions to be taken in order ... unnatural disasters. , Yisrayl says scientists have yet to understand fully the real ...
(Date:8/28/2015)... BOSTON, MA (PRWEB) , ... August 28, 2015 ... ... WorldCare International, Inc. ’s online medical consultations result in high percentages of change ... performed by the Center for Healthcare Informatics at Tennessee Tech University and analyzed ...
(Date:8/28/2015)... ... August 28, 2015 , ... On October 3, 2015, BethAnn Telford of TeamBT ... the Grand Canyon with a shared mission: to beat brain cancer. In one grueling ... the canyon, then up to the South Rim over 21.1 miles and more than 10,000 ...
(Date:8/27/2015)... ... ... This new webinar educates providers about how can they create a scalable and ... authorizations are in check, and they are current with their payments. Learn ... Software, growing a practice depends on patient experience and clinician’s relationship with the patient. ...
(Date:8/27/2015)... ... August 27, 2015 , ... In the addiction treatment industry, some ... months later, relapsing and returning again, all at great cost to them and their ... living homes or soon after leaving facilities who claim to have given addicts tools ...
Breaking Medicine News(10 mins):Health News:Wake Up and Smell the Sick Atmosphere Says Yisrayl Hawkins in New Article This Week 2Health News:WorldCare International, Inc. Celebrates Findings of Independent ROI Study 2Health News:Women Athletes Cross the Grand Canyon to Raise Funds for Brain Cancer Research – October 3rd 2Health News:A New Webinar Teaches Chiropractors How to Use Compliance Alerts to Manage Patient Relationships 2Health News:National Screenings of Documentary Indicate Burgeoning Questions about the Effectiveness of Addiction Treatment Facilities 2Health News:National Screenings of Documentary Indicate Burgeoning Questions about the Effectiveness of Addiction Treatment Facilities 3
... the billions of pounds being spent on hospitals for the NHS ... of care.// ,The report has claimed that the NHS ... 30 years to pay off, when the present plans for the ... people live. ,According to this report the Department of ...
... have suggested that some links exist between Alzheimer's and Type ... two are actually// different forms of the same disease. ... causes to the pancreas is similar to the effect of ... on Saturday during the International Conference on Alzheimer's Disease and ...
... the lowest number of reported HIV/Aids cases in the world ... prove it.// ,This was the conclusion of the ... Ministry of Health. Neighboring countries have also reported a similar ... behavioral norms have contributed to keeping infection at very low ...
... sleep-deprived youth working continuously on night shifts in BPO ... night, skipping breakfast, eating lunch in the evening and ... Lim Li Ling, Deputy Director, sleep disorders unit, Singapore ... would be affected due to lack of proper sleep, ...
... Indian Ocean such as Mauritius have been struck by a ... far, according to doctors. // ,The chikungunya virus ... and rashes and is potentially lethal. It has ravaged the ... Researchers from the University of Lausanne, Switzerland have reported the ...
... U.S. are suffering from long-term spinal cord injuries, with more ... ,One study appearing in the July 12th issue of the ... towards providing evidence that a combination of treatments could lead ... The result would be a return of functional activity. ...
Cached Medicine News:Health News:Diabetes and Alzheimer's disease May be Two Sides of the Same Coin 2
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... 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 ...
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... 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 ...
Medicine Products: