Navigation Links
Digestive Care, Inc. Receives Complete Response Letter from FDA for PANCRECARB(R) (pancrelipase)
Date:9/14/2009

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.

About PANCRECARB((R))

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 www.digestivecare.com.


'/>"/>
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:
*Name:
*Comment:
*Email:
(Date:1/20/2017)... ... ... account following a man who went on to support his country and serve the Lord. ... Haven, Florida and at the age of 5, his family moved to Pensacola Florida. In ... and got married right out of boot camp. , He and his wife raised ...
(Date:1/20/2017)... , ... January 20, 2017 , ... “Journey to Christmas:” a beautiful and enchanting tale ... published author, Kimberly Cordoves, a mother of three in Oklahoma City, and a devoted woman ... of writing a book has been in the back of my mind for years, but ...
(Date:1/19/2017)... ... January 20, 2017 , ... Today, the Centers for Medicare & ... of CMS’s Alternative Payment Models (APMs) in 2017. Clinicians who participate in APMs are ... an important part of the Administration’s effort to build a system that delivers better ...
(Date:1/19/2017)... ... ... here, many people will have to clear snow with snow blowers or shovels from driveways ... can be dangerous when used incorrectly. That’s why Amica Insurance is sharing the ... blowers:, , When removing wet snow or debris from the blower, ...
(Date:1/19/2017)... ... January 19, 2017 , ... Remote Medical Technologies (RMT), ... transportable capabilities with their iMedHD2™ Portable Teleultrasound System. Compatible with ... that delivers HD, dynamic, streaming ultrasound images and video to one or more ...
Breaking Medicine News(10 mins):
(Date:1/19/2017)... -- Report Details ... Alzheimer,s Disease Therapeutics and Diagnostics ... new study reveals trends, R&D progress, and predicted revenues ... Alzheimer,s disease therapeutics and diagnostics market. Our new report ... How is the Alzheimer,s disease therapeutics and diagnostics market ...
(Date:1/19/2017)... 19, 2017  Stealth BioTherapeutics Inc. ( Stealth ), ... dysfunction, today announced new additions to its senior leadership ... Medical Officer, and Daniel Geffken as interim ... Jim Carr , Pharm.D. has been promoted to Chief ... to welcome Doug and Daniel to our management team, ...
(Date:1/19/2017)... SUNNYVALE, Calif. , Jan. 19, 2017 ... that its CyberKnife® and TomoTherapy® Systems continue to set ... systems received the highest composite overall user satisfaction rating ... to the Q4 2016 MD Buyline Market Intelligence Briefing™. ... achieved the highest composite ratings among industry peers for ...
Breaking Medicine Technology: