Solvay's Creon gets FDA "approvable" letter

Solvay Pharmaceuticals, the US subsidiary of Belgian drug and chemicals firm Solvay, says it has received an "approvable" letter from the Food and Drug Administration for its drug Creon (pancrelipase delayed-release capsules). The firm needs to provide additional clinical data, and Chemistry, Manufacturing and Controls information to the federal agency prior to approval

Creon, which is a treatment for the pancreatic exocrine insufficiency associated with cystic fibrosis, has been marketed in the USA for 20 years. Solvay explained that it submitted the drug to the FDA in an effort to comply with the agency's 2004 publication of a Federal Register Notice requesting that all manufacturers of pancreatic enzyme products obtain New Drug Application approval.

Laurence Downey, president and chief executive of Solvay Pharmaceuticals, said: "we are confident that our ongoing clinical work that was initiated prior to receiving this letter will satisfy the FDA's request."