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:3/29/2017)... ... 29, 2017 , ... Dr. Angela Cotey, a noted general dentist in Mt. ... patients, with or without a referral. Dr. Cotey knows that interceptive orthodontics ... experience. When patients receive early treatment, they may achieve straight teeth with less treatment ...
(Date:3/29/2017)... ... 2017 , ... An inventor from Raynham, Mass., knows the ... conjunction with my braces always rubbed against the inside of my cheeks, causing ... problem." The O.B.S. was the result of his brainstorming. , This patent-pending invention ...
(Date:3/29/2017)... , ... March 29, 2017 ... ... and South Hills of Pittsburgh now have easier access to the robotic-assisted ... by Allegheny Health Network (AHN). Orthopaedic surgeons at Forbes Hospital and Jefferson ...
(Date:3/28/2017)... ... March 28, 2017 , ... A recent Bellwether Education ... quality, the field must first improve teacher preparation program design. It then asserts ... and that decades of input- and outcome-based research has failed to improve teacher ...
(Date:3/28/2017)... ... March 28, 2017 , ... Resoundant, ... be invited to the Siemens Healthineers annual customer education symposium, a world-class learning ... take place from March 27 - 31, 2017 at the Atlanta Marriott Marquis ...
Breaking Medicine News(10 mins):
(Date:3/28/2017)... , March 28, 2017 The ... (dupilumab) injection to treat adults with moderate-to-severe eczema ... eczema is not controlled adequately by topical therapies, ... advisable. Dupixent can be used with or without ... demonstrates our commitment to approving new and innovative ...
(Date:3/28/2017)...  "US Cancer Generics Market Outlook 2022" report ... trend analysis related to the emergence and integration ... in US. The report analyzes various clinical and ... generics drugs in recent years. The introduction of ... dollars for various stake holders involved US cancer ...
(Date:3/28/2017)... , Va. and PHOENIX , March 28, ... Avella Specialty Pharmacy released a new white ... allergies and the use of latex in healthcare. Specifically, there ... in healthcare. In fact, the FDA has urged manufacturers to ... latex" claim from labels, because of the challenge to ensure ...
Breaking Medicine Technology: