Navigation Links
Digestive Care, Inc. Receives Complete Response Letter from FDA for PANCRECARB(R) (pancrelipase)

BETHLEHEM, Pa., Sept. 14 /PRNewswire/ -- Digestive Care, Inc. (DCI) announced today that the company has received a complete response letter from the U.S. Food and Drug Administration (FDA) and has moved closer to obtaining approval of its New Drug Application (NDA) for PANCRECARB((R) )(pancrelipase) used for the treatment of Exocrine Pancreatic Insufficiency.

DCI has been working closely with the FDA throughout the NDA process and will submit a complete and timely response to the Agency's requests. DCI is not required to conduct additional clinical trials on PANCRECARB((R) )prior to NDA approval. "We are pleased to have reached this important milestone and are committed to satisfying the Agency's remaining requests," said Dr. Tibor Sipos, President and Chief Scientific Officer.


PANCRECARB((R) )is a pancreatic enzyme replacement therapy for the treatment of Exocrine Pancreatic Insufficiency and has been marketed in the United States for over a decade. 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.

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 technology of DCI 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) which is manufactured in the USA. For information, please visit us at

SOURCE Digestive Care, Inc.
Copyright©2009 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:
(Date:6/24/2016)... ... June 24, 2016 , ... Dr. Amanda Cheng, an ... Cheng has extensive experience with all areas of orthodontics, including robotic Suresmile technology, ... , Micro-osteoperforation is a revolutionary adjunct to orthodontic treatment. It can be ...
(Date:6/24/2016)... NY (PRWEB) , ... June 24, 2016 , ... Topical BioMedics, Inc, makers of Topricin ... companies that call for a minimum wage raise to $12 an hour by 2020 and ... This will restore the lost value of the minimum wage, assure the wage floor does ...
(Date:6/24/2016)... (PRWEB) , ... June 24, 2016 , ... ... today at the Clinical Decision Making in Emergency Medicine conference in Ponte Vedra ... authored journal articles published in Emergency Medicine Practice and Pediatric Emergency ...
(Date:6/24/2016)... Las Vegas, Nevada (PRWEB) , ... June 24, ... ... their Las Vegas client, The Grove Investment Group (TGIG), has initiated cultivation and ... The Grove, in Las Vegas and Pahrump, Nevada. , Puradigm is the manufacturer ...
(Date:6/24/2016)... ... ... National recruitment firm Slone Partners is pleased to announce the placement of ... President of North American Capital Sales at HTG Molecular . , ... the commercialization of the HTG EdgeSeq system and associated reagents in North America. , ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... -- MedSource announced today that it has selected Datatrial,s ... choice.  This latest decision demonstrates MedSource,s commitment to ... by offering a state-of-the-art electronic data capture (EDC) ... the EDC platform of choice in exchange for ... long been a preferred EDC platform by our ...
(Date:6/23/2016)... Research and Markets has announced ... Type (Organic Chemical (Sugar, Petrochemical, Glycerin), Inorganic Chemical), Functionality ... - Global Forecast to 2021" report to their ... global pharmaceutical excipients market is projected to reach USD ... in the forecast period 2016 to 2021. ...
(Date:6/23/2016)... June 23, 2016 Research and Markets ... Medical Market Analysis 2016 - Forecast to 2022" report ... The report contains up to date financial data derived from ... of major trends with potential impact on the market during ... market segmentation which comprises of sub markets, regional and country ...
Breaking Medicine Technology: