The U.S. Food and Drug Administration wants more information about a proposed drug from Solvay Pharmaceuticals that targets a pancreatic condition, the company said Monday.
In a letter, the FDA said Solvay needed to provide more information about Creon. Solvay had filed a new drug application for Creon, which is intended to be a treatment for pancreative exocrine insufficiency, which is often associated with cystic fibrosis and chronic pancreatitis.
“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 chief executive officer at Solvay.
