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news.Solvay Pharmaceuticals has received an approvable letter from the FDA with respect to its new drug application for Creon, a pancreatic enzyme for the treatment of pancreatic exocrine insufficiency, which is often associated with cystic fibrosis and chronic pancreatitis.
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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 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, president and CEO, Solvay Pharmaceuticals. “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.”