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:5/26/2017)... ... 26, 2017 , ... Boar’s Head Brand®, one of the ... Day entertaining that are sure to satisfy your guests’ flavor cravings, while adding ... cheeses featured in these refreshingly balanced recipes are packed with flavor, creating the ...
(Date:5/26/2017)... ... May 26, 2017 , ... Yisrayl Hawkins, Pastor and Overseer at The ... is focusing on the Peace Agreements being discussed by President Donald Trump and the ... race to try to speed up peace talks in the continuous battle between Israel ...
(Date:5/26/2017)... ... May 26, 2017 , ... “When the Stars Lead Home”: ... the creation of published author Laura Weigel Douglas, an avid reader who lives in ... house that sometimes feels like Green Hills Adventure Camp. She couldn’t be more grateful. ...
(Date:5/26/2017)... (PRWEB) , ... May 26, 2017 , ... “Cactus Jack: ... had on so many others. “Cactus Jack: Against All Odds” is the creation ... Walter D. Hubbard is married to Jack Carlisle’s third child Jane. Walter. ...
(Date:5/24/2017)... ... 2017 , ... Dr. Alan I. Benvenisty, MD is dual board certified in ... known for his distinguished expertise and experience in the diagnosis and treatment of vascular ... treating renovascular disease and aortic aneurysm . He is known for his minimally ...
Breaking Medicine News(10 mins):
(Date:5/11/2017)... 11, 2017  Thornhill Research Inc. ( ... an $8,049,024 USD five-year, firm-fixed-priced, indefinite-quantity/indefinite-delivery contract by ... Commercial Corporation (CCC) ( Ottawa, Ontario, Canada ... administer general anesthesia to patients requiring emergency medical ... US Marine Corps have been a longtime partner ...
(Date:5/10/2017)... 10, 2017 Global Health Intelligence (GHI), ... America , published its 2017 ranking of the ... on extensive data analysis from GHI,s hospitals database for ... for the region. The GHI database covers 86% of the ... than 130 data points for each institution in key areas ...
(Date:5/10/2017)... May 10, 2017 Radiology has become the ... costs have also spiraled to the number one ranking ... radiology than ever before as the most complete and ... patient with lower back pain an MRI may confirm ... for pain, resulting in entirely different treatment protocols.  In ...
Breaking Medicine Technology: