Navigation Links
Digestive Care, Inc. Announces the Filing of the First Module of NDA Submission for PANCRECARB(R) (pancrelipase)
Date:7/7/2008

BETHLEHEM, Pa., July 7 /PRNewswire/ -- Digestive Care, Inc. (DCI) announced today that it has submitted the first module of its New Drug Application ("NDA") for PANCRECARB(R) (pancrelipase), used in the treatment of Exocrine Pancreatic Insufficiency ("EPI"), with the U.S. Food and Drug Administration ("FDA"). The FDA has granted the product Fast Track designation.

"Digestive Care has provided vital products used to treat EPI for over a decade and we are committed to filing the remaining modules for the NDA for PANCRECARB(R) to meet the April 28, 2009 requirements set forth by the FDA," said Dr. Tibor Sipos, President and Chief Scientific Officer. "Digestive Care is committed to improving the quality of life for individuals suffering from chronic illnesses such as Cystic Fibrosis," added Dr. Sipos.

In addition, Digestive Care recently completed a randomized, double-blind, placebo-controlled, multi-center, crossover study on PANCRECARB(R) MS-16. The clinical trial was conducted at 5 centers and included 21 subjects. The results will soon be published at upcoming scientific meetings.

About PANCRECARB(R)

PANCRECARB(R) is a pancreatic enzyme replacement therapy for the treatment of Exocrine Pancreatic Insufficiency. It is the only enteric coated, bicarbonate buffered pancreatic enzyme available on the market today, and several U.S. patents protect PANCRECARB(R). In April 2004, the FDA determined that prescription Exocrine Pancreatic Insufficiency drug products are medically necessary and, accordingly, allowed the drug manufacturers four years (April 2008) to obtain approved new drug applications. The FDA then announced the deadline extension for unapproved pancreatic enzyme drug products to April 28, 2010, but only if the manufacturers have investigational new drug applications on active status on or before April 28, 2008 and have submitted NDAs on or before April 28, 2009. PANCRECARB(R) is on track to fulfill these requirements.

'/>"/>
SOURCE Digestive Care, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2

Related medicine news :

1. VIDEO from Medialink and General Mills: Digestive Health
2. Despite Advances in the Accuracy of CT Colonography in Detecting Polyps, Digestive Health Experts Urge Patients to Consider Risks and Realities
3. Raw Seafood Poses Digestive Risks
4. AUDIO from Medialink and Kellogg: Ten Delicious Days to Better Digestive Health
5. AUDIO from Medialink and Kelloggs: Ten Delicious Days to Better Digestive Health
6. Digest This: Digestive Health Harder to Maintain Than Financial Health
7. Mayo Clinic Proceedings Examines a Possible Link Between Bacteria Found in the Human Digestive System and Obesity
8. Mayo Clinic Proceedings examines link between bacteria in the digestive system and obesity
9. TAK-390MR Phase 3 data presented at Digestive Disease Week
10. New Friendship Cottage Cheese Boosts Digestive & Bone Health
11. North South Divide Exists in UK Digestive Health
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/29/2014)... CA (PRWEB) July 29, 2014 Oxnard ... the Anacapa Dental Art Institute in Oxnard and Woodland Hills, ... have fallen out or been removed due to dental disease. ... and the two prosthodontists (experts in restoring and replacing teeth) ... not using implant specialists to perform their dental work and ...
(Date:7/29/2014)... Lean and Lovely, an affordable and short ... want to wear a bikini in the near future. This ... investigative review. , “Our Lean and Lovely review ... all fitness levels. Neither your age nor your body shape ... is at the beginning, you will achieve the results that ...
(Date:7/29/2014)... (PRWEB) July 29, 2014 The ... project, The Cottages at MeadowLands Memory Care, to break ... of those suffering from memory loss and forms of ... has approved the development of Oconto Fall’s first assisted ... Peterson, GM of The Cottages Investment Group, LLC will ...
(Date:7/29/2014)... Couples rule at Maui's only Forbes Five ... This September through November, the focus is on activities and ... of all ages and interests. Best of all, the ... the Resort's popular Experience More package , with resort ... is in full swing in the award-winning restaurants, spa and ...
(Date:7/29/2014)... 2014 Guests at Napa Valley's quintessential luxury ... a new sleep experience. The top of each luxurious resort ... , These expertly crafted, 100% Egyptian cotton white duvets ... distance, yet upon closer look, words are woven in the ... and breathe. , Intentional breathing and visualization are ...
Breaking Medicine News(10 mins):Health News:Oxnard Dental Implant Experts Warn of Infections Around Dental Implants 2Health News:Oxnard Dental Implant Experts Warn of Infections Around Dental Implants 3Health News:Oxnard Dental Implant Experts Warn of Infections Around Dental Implants 4Health News:Lean and Lovely: Review Examining Neghar Fonooni’s Program Released 2Health News:The Cottages Investment Group Announces Third Development Project, The Cottages at MeadowLands Memory Care, Oconto Falls 2Health News:The Cottages Investment Group Announces Third Development Project, The Cottages at MeadowLands Memory Care, Oconto Falls 3Health News:The Cottages Investment Group Announces Third Development Project, The Cottages at MeadowLands Memory Care, Oconto Falls 4Health News:Four Seasons Resort Maui at Wailea Goes All Out to Give Couples Memorable Get-Away this Fall at Maui’s Luxury Resort 2Health News:Four Seasons Resort Maui at Wailea Goes All Out to Give Couples Memorable Get-Away this Fall at Maui’s Luxury Resort 3Health News:Auberge Du Soleil Offers INTENTIONS™ by Peacock Alley on Guests' Beds Providing a Unique Sleep Experience 2
... kits from Beacon Analytical Systems and, ... SoftMax(R), Pro analytical software,SUNNYVALE, CA, Feb. ... innovative solutions for drug discovery and life sciences research, ... Melamine Plate Kit from Beacon Analytical Systems, which focuses ...
... 19 The Providence Service Corporation (Nasdaq: ... been awarded a $1.5 million annual contract to operate ... County, California. The contract is being funded through ... voters as Proposition 63."Our home and community based delivery ...
... Feb. 19 Based on its recent analysis of ... recognizes Horphag Research Ltd. with the 2008 North American ... Award. The award acknowledges the company,s extensive research projects ... at validating the health benefits of the ingredient, Pycnogenol(R), ...
... ST. PETERSBURG, Fla., Feb. 19 Smith & Nephew,s ... SNN ) announced that the United States Patent and ... of KCI,s negative pressure wound therapy (NPWT) patents during ... The Patent Office found that prior art showed ...
... Highlights:- Adjusted EPS from continuing operations of $0.70, ... from continuing operations of $0.65, up 18.3% - ... CVS Caremark Corporation (NYSE: CVS ... earnings for the fourth quarter and year ended ...
... Whether it is due to allergies, gluten intolerance, autism, ... eliminate ingredients such as gluten or milk. Likewise, ... seek relief by using air purifiers and non-toxic cleaning, ... daughters with multiple food and environmental allergies wanted to ...
Cached Medicine News:Health News:MDS Analytical Technologies Announces Validation of Two More Kits for High-Throughput Detection of Melamine in Food 2Health News:MDS Analytical Technologies Announces Validation of Two More Kits for High-Throughput Detection of Melamine in Food 3Health News:MDS Analytical Technologies Announces Validation of Two More Kits for High-Throughput Detection of Melamine in Food 4Health News:Providence Service Corporation California Subsidiary Awarded $1.5 Million Contract Under State's Mental Health Services Act 2Health News:Frost & Sullivan Recognizes Horphag's Pioneering R&D Efforts in Health Ingredients 2Health News:Frost & Sullivan Recognizes Horphag's Pioneering R&D Efforts in Health Ingredients 3Health News:Frost & Sullivan Recognizes Horphag's Pioneering R&D Efforts in Health Ingredients 4Health News:United States Patent Office Rejects KCI's Patents 2Health News:United States Patent Office Rejects KCI's Patents 3Health News:CVS Caremark Reports Record Results in Fourth Quarter and Year 2008 2Health News:CVS Caremark Reports Record Results in Fourth Quarter and Year 2008 3Health News:CVS Caremark Reports Record Results in Fourth Quarter and Year 2008 4Health News:CVS Caremark Reports Record Results in Fourth Quarter and Year 2008 5Health News:CVS Caremark Reports Record Results in Fourth Quarter and Year 2008 6Health News:CVS Caremark Reports Record Results in Fourth Quarter and Year 2008 7Health News:CVS Caremark Reports Record Results in Fourth Quarter and Year 2008 8Health News:CVS Caremark Reports Record Results in Fourth Quarter and Year 2008 9Health News:CVS Caremark Reports Record Results in Fourth Quarter and Year 2008 10Health News:CVS Caremark Reports Record Results in Fourth Quarter and Year 2008 11Health News:CVS Caremark Reports Record Results in Fourth Quarter and Year 2008 12Health News:CVS Caremark Reports Record Results in Fourth Quarter and Year 2008 13Health News:CVS Caremark Reports Record Results in Fourth Quarter and Year 2008 14Health News:CVS Caremark Reports Record Results in Fourth Quarter and Year 2008 15Health News:CVS Caremark Reports Record Results in Fourth Quarter and Year 2008 16Health News:CVS Caremark Reports Record Results in Fourth Quarter and Year 2008 17Health News:CVS Caremark Reports Record Results in Fourth Quarter and Year 2008 18Health News:CVS Caremark Reports Record Results in Fourth Quarter and Year 2008 19Health News:CVS Caremark Reports Record Results in Fourth Quarter and Year 2008 20Health News:CVS Caremark Reports Record Results in Fourth Quarter and Year 2008 21Health News:CVS Caremark Reports Record Results in Fourth Quarter and Year 2008 22Health News:CVS Caremark Reports Record Results in Fourth Quarter and Year 2008 23Health News:Coming Clean: New Allergy Specialty Store is Land of Plenty for All People With Allergies 2
(Date:7/28/2014)... , July 28, 2014 Reportbuyer.com has ... Global Bone Densitometers Market 2014-2018 ... bone densitometry scan is a special type of X-ray ... bone. It is used primarily to detect osteopenia or ... and the risk of fractures is high. The purpose ...
(Date:7/28/2014)... , July 28, 2014 KaloBios Pharmaceuticals, Inc. ... on the status of the KB001-A development program, including ... KB001-A Collaboration Update ... Sanofi Pasteur to regain all rights to KaloBios, KB001-A ... entered into in 2010 has been terminated. Under that ...
(Date:7/28/2014)... , July 28, 2014  Some 2,500 scientists and ... in Montreal for the largest ... a discipline that draws researchers from fields as far ... as diverse as designing new manufacturing processes to creating ... special time because the United Nations has declared 2014 ...
Breaking Medicine Technology:Global Bone Densitometers Market 2014-2018 2Global Bone Densitometers Market 2014-2018 3Global Bone Densitometers Market 2014-2018 4Global Bone Densitometers Market 2014-2018 5KaloBios Provides Update on KB001-A Partnership and Clinical Status 2KaloBios Provides Update on KB001-A Partnership and Clinical Status 3KaloBios Provides Update on KB001-A Partnership and Clinical Status 4KaloBios Provides Update on KB001-A Partnership and Clinical Status 5KaloBios Provides Update on KB001-A Partnership and Clinical Status 6All About Crystals: Tiny, Giant, from Mars, from Earth's Mantle, in Medicine and in Manufacturing 2All About Crystals: Tiny, Giant, from Mars, from Earth's Mantle, in Medicine and in Manufacturing 3All About Crystals: Tiny, Giant, from Mars, from Earth's Mantle, in Medicine and in Manufacturing 4All About Crystals: Tiny, Giant, from Mars, from Earth's Mantle, in Medicine and in Manufacturing 5All About Crystals: Tiny, Giant, from Mars, from Earth's Mantle, in Medicine and in Manufacturing 6
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
Medicine Products: