Solvay wins FDA approvable letter for Creon pancreatic enzyme

Belgium-headquartered Solvay Pharmaceuticals has received an approvable letter from the FDA with respect to its New Drug Application (NDA) for Creon (pancrelipase delayed-release capsules), a pancreatic enzyme for the treatment of pancreatic exocrine insufficiency associated with cystic fibrosis and chronic pancreatitis.

In April 2004, the FDA published a Federal Register Notice requiring all manufacturers of pancreatic enzyme products to obtain NDA approval. Solvay Pharmaceuticals' application is intended to comply with the FDA's guidance, which defines the requirements for approval.

The FDA stated in its letter that the company would need to provide additional clinical data and Chemistry, Manufacturing and Controls (CMC) information prior to approval.

Dr Laurence Downey, president and CEO of Solvay's US arm, said: "We are confident that our ongoing clinical work that was initiated prior to receiving this letter will satisfy the FDA's request. Creon helps meet a critical medical need for thousands of patients who suffer from cystic fibrosis and pancreatic insufficiency and we will continue to work with the Agency to gain approval for this life-sustaining drug."