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.

About Digestive Care, Inc.

DCI is a privately held fully integrated pharmaceutical company dedicated to developing unique pharmaceutical products to alleviate complications and symptoms of gastrointestinal disorders. DCI was founded in 1990. The company holds 15 U.S. and foreign patents and has a national distribution network. The Company's technology is based on the ability to commercially develop unique drug delivery systems for delivering bioactive molecules to their target site. The company has grown from an initial research based organization to a fully integrated pharmaceutical company encompassing Research, Product Development, Manufacturing, Packaging, Distribution, Marketing, and Sales. DCI's research into the controlled delivery of gastric acid resistant digestive enzymes and buffered bile acids through micro encapsulation led to the development of the successful drug product, PANCRECARB(R) (pancrelipase). For information, please visit us at http://www.digestivecare.com.


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

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:2/5/2016)... ... 05, 2016 , ... In sleep, when the defenses of the day are ... of patients with eating disorders is significant self-criticism, and consequently these patients experience this ... regarded as maladaptive means for coping with this unease, but also leads to a ...
(Date:2/5/2016)... ... 2016 , ... California Mobile Kitchens , a company ... latest mobile kitchen model, featuring customizable stainless steel interiors and a new, 26-foot ... use anywhere in the U.S. Many of their units can be seen at ...
(Date:2/5/2016)... ... 05, 2016 , ... Calls Blacklist has just been updated by mobile app ... the developer has fixed known bugs within the app. Calls Blacklist allows its users ... not consuming any of their device’s battery power or memory. It provides a powerful ...
(Date:2/5/2016)... ... ... –This week, Atascadero water heater company First Call Plumbing has ... the report, click here or see below. , There are two ... cons, the type chosen is almost entirely up to personal preference. However, tankless water ...
(Date:2/5/2016)... ... ... one is tired of trying to cram belongings into spare space that just isn’t there, ... unit, but before hastily spending money on a unit, take these tips into consideration. , ... one is often not told when utilizing these services are some tips on how to ...
Breaking Medicine News(10 mins):
(Date:2/4/2016)... -- Frontier Pharma: Chronic Obstructive Pulmonary Disease (COPD) ... Chronic Obstructive Pulmonary Disease (COPD) is a ... airways and lungs. Persistent breathing difficulties and repeated ... of the leading causes of morbidity and the ... is linked to cumulative exposure to risk factors, ...
(Date:2/4/2016)... 2016  Aethlon Medical, Inc. (Nasdaq: AEMD ... to treat life-threatening diseases, today announced results for ... 31, 2015. --> ... in our last quarterly call, we strategically advanced ... objective to establish the Aethlon Hemopurifier® as a ...
(Date:2/4/2016)... , Feb. 4, 2016  Blueprint Medicines Corporation ... and developing highly selective investigational kinase medicines for ... appointment to its board of directors of ... nearly 30 years of industry-related experience. ... Blueprint Medicines. "Lonnel,s strong strategic experience developing and ...
Breaking Medicine Technology: