Navigation Links
Digestive Care, Inc. Announces the Complete Submission of the NDA for PANCRECARB(R) (pancrelipase)
Date:10/27/2008

BETHLEHEM, Pa., Oct. 27 /PRNewswire/ -- Digestive Care, Inc. (DCI) announced today that it has completed the submission of the New Drug Application ("NDA") for PANCRECARB(R) (pancrelipase), used in the treatment of Exocrine Pancreatic Insufficiency ("EPI"), to the U.S. Food and Drug Administration ("FDA"). The FDA had previously granted the product Fast Track designation and approved a rolling NDA submission schedule.

"Digestive Care has provided vital products used to improve the nutritional status of patients living with chronic diseases, such as cystic fibrosis, for over a decade. We are excited about the results of our Clinical Trials submitted with the PANCRECARB(R) NDA, and are pleased to have completed the NDA submission prior to the April 28, 2009 deadline set forth by the FDA," said Dr. Tibor Sipos, President and Chief Scientific Officer. "PANCRECARB(R) is a unique bicarbonate buffered enteric-coated formulation of pancrelipase that has been an essential component of the armamentarium for the treatment of EPI associated with cystic fibrosis (CF) and other diseases affecting the pancreas. We are dedicated to continuing to provide PANCRECARB(R) to CF patients and others suffering from EPI," added Dr. Sipos.

The results of the recently completed randomized, double-blind, placebo-controlled, multi-center, crossover study on PANCRECARB(R) MS-16 was presented at the 2008 North American Cystic Fibrosis Conference, October 23-25 in Orlando, Florida.

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.

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 http://www.digestivecare.com.


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

Related medicine news :

1. MyHealthGate, Inc. Joins With LiveActive Chewy Granola Bars to Raise Digestive Health Awareness
2. 2009 Half Marathon Training Program to Benefit Research into Debilitating Digestive Diseases
3. Obesity raises risks of serious digestive health concerns
4. String probes for devastating childhood digestive disease
5. Digestive Disease Week study examined ACRs guidelines for CT colonography interpretation
6. Digestive Care, Inc. Announces the Filing of the First Module of NDA Submission for PANCRECARB(R) (pancrelipase)
7. North South Divide Exists in UK Digestive Health
8. New Friendship Cottage Cheese Boosts Digestive & Bone Health
9. TAK-390MR Phase 3 data presented at Digestive Disease Week
10. Mayo Clinic Proceedings examines link between bacteria in the digestive system and obesity
11. Mayo Clinic Proceedings Examines a Possible Link Between Bacteria Found in the Human Digestive System and Obesity
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/4/2016)... ... December 03, 2016 , ... Penrose Senior ... the Dallas area” Tuesday evening at the 26th Annual SMU Cox Dallas 100™ ... Cox School’s Caruth Institute for Entrepreneurship. Dallas 100™, co-founded by the Caruth Institute, ...
(Date:12/4/2016)... ... December 04, 2016 , ... Patients who wish ... take advantage of a cosmetic procedure known as Carbon Dioxide (C02) Fractional ... appearance of age spots, fine lines, uneven coloration, wrinkles, scarring, skin laxity ...
(Date:12/4/2016)... ... December 04, 2016 , ... Responsible dental care hinges ... brush properly to achieve optimal results. This important necessity inspired an inventor from Las ... a way to ensure that people break or avoid bad techniques of brushing the ...
(Date:12/2/2016)... ... December 02, 2016 , ... Lori G. Cohen ... Atlanta office, will speak at the American Conference Institute’s 21st Drug & Medical ... also a Lead Sponsor of the conference. , Cohen, who chairs the firm’s Pharmaceutical, ...
(Date:12/2/2016)... , ... December 02, 2016 , ... On Dec. 2, ... Hard Rock Hotel San Diego honoring the 2016 MPN Heroes—eight individuals who have made ... by going above and beyond the standard of care, demonstrating leadership within the MPN ...
Breaking Medicine News(10 mins):
(Date:12/5/2016)... , Dec 5, 2016 Research ... Market by Product (Instruments, Consumables), Application (Biomedical & Biochemical Research, Disease ... - Global Forecasts to 2021" report to their offering. ... , , ... USD 730.7 Million in 2021 from USD 574.8 Million in 2016, ...
(Date:12/5/2016)...   BIOTRONIK today announced the first patients ... the safety and feasibility of performing the minimally invasive ... BioMonitor 2 is an insertable cardiac remote monitor ... a patient,s skin to help physicians accurately detect and ... a leading cause of stroke and heart failure. BioMonitor ...
(Date:12/5/2016)... Dec. 5, 2016  CVS Health, the nation,s largest ... a perfect score of 100 percent on the Corporate ... CEI is an annual national benchmarking survey and report ... administered by the Human Rights Campaign Foundation. ... that our colleagues, customers and suppliers bring to CVS ...
Breaking Medicine Technology: