15. September 2009 01:08
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.
Source: http://www.digestivecare.com
News-Medical.Net provides this medical information service in accordance
with these
terms and conditions.
Please note that medical information found
on this website is designed to support, not to replace the relationship
between patient and physician/doctor and the medical advice they may provide.
Subscribe