MARIETTA, Ga.--(BUSINESS WIRE)--Solvay Pharmaceuticals, Inc. today announced it has received an approvable letter from the U.S. Food and Drug Administration (FDA) with respect to its New Drug Application (NDA) for CREON®. CREON® (pancrelipase delayed-release capsules, USP) is a pancreatic enzyme for the treatment of pancreatic exocrine insufficiency as is often associated with cystic fibrosis and chronic pancreatitis.
On April 28, 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.
In its approvable letter to Solvay Pharmaceuticals, the FDA stated that the company would need to provide additional clinical data and Chemistry, Manufacturing and Controls (CMC) information prior to approval.
"We are confident that our ongoing clinical work that was initiated prior to receiving this letter will satisfy the FDA's request," said Laurence Downey, M.D., president and CEO, Solvay Pharmaceuticals, Inc. "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."
CREON® is the top-prescribed pancreatic enzyme in the United States and has been marketed in the United States for 20 years. Solvay Pharmaceuticals benefits from more than 100 years of experience with pancreatic enzyme products globally.
CREON® (pancrelipase delayed-release capsules, USP) is indicated for patients with pancreatic exocrine insufficiency. The most frequently reported adverse reactions to pancreatic enzyme-containing products are gastrointestinal in nature, which may include nausea, vomiting, bloating, cramping, constipation or diarrhea. Less frequently, allergic-type reactions have also been observed. Very high doses of pancreatin have been associated with hyperuricosuria and hyperuricemia. Full prescribing information is available at www.solvaypharmaceuticals-us.com.
About Solvay Pharmaceuticals Inc.
Solvay Pharmaceuticals Inc., of Marietta, Ga., is the U.S. subsidiary of Solvay Pharmaceuticals. For more information, visit www.solvaypharmaceuticals-us.com.
Solvay Pharmaceuticals is a research driven group of companies that constitutes the global pharmaceutical business of the Solvay Group. The company seeks to fulfill carefully selected, unmet medical needs in the therapeutic areas of neuroscience, cardiometabolic, influenza vaccines, gastroenterology, and men's and women's health. Its 2006 sales were EUR 2.6 billion and it employs approximately 10,000 people worldwide. For more information, visit www.solvaypharmaceuticals.com.
SOLVAY is an international chemical and pharmaceutical Group with headquarters in Brussels. It employs some 29,000 people in 50 countries. In 2006, its consolidated sales amounted to EUR 9.4 billion generated by its three activity sectors: Chemicals, Plastics and Pharmaceuticals. Solvay (NYSE Euronext : SOLB.BE - Bloomberg: SOLB.BB - Reuters: SOLBt.BR) is listed on the NYSE Euronext stock exchange in Brussels. Details are available at www.solvay.com.
Solvay Pharmaceuticals, Inc.
Neil Hirsch, 770-578-2170
Manager, U.S. Corporate Communications
Source: Solvay Pharmaceuticals, Inc.