DCI Receives Complete Response Letter For Pancrecarb

Digestive Care (DCI) has received a complete response letter from the FDA and has moved closer to obtaining approval of its New Drug Application (NDA) for Pancrecarb (pancrelipase).

Pancrecarb is a pancreatic enzyme replacement therapy for the treatment of exocrine pancreatic insufficiency.

Reportedly, 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 prior to NDA approval.

Tibor Sipos, president and chief scientific officer at DCI, said: “We are pleased to have reached this important milestone and are committed to satisfying the Agency’s remaining requests.”