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Home Industry News Solvay: Creon helps meet critical medical need

Solvay: Creon helps meet critical medical need

21st August 2007

Solvay Pharmaceuticals has reported that its pancreatic enzyme Creon (pancrelipase delayed-release capsules, USP), helps meet a need for the treatment of pancreatic exocrine insufficiency related to chronic pancreatitis and cystic fibrosis.

The company has this week received an approval letter from the US Food and Drug Administration (FDA) for the compound relating to this indication.

Following the receipt of this letter, Solvay must provide the regulatory authority with further clinical data, in addition to chemistry, manufacturing and controls information, before the drug can be granted marketing authorisation for this disease.

Laurence Downey, president and chief executive officer of Solvay, said: “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.”

He added that the firm is confident that its continuing clinical studies that have been ongoing prior to receipt of this letter will provide sufficient information to satisfy the request from the FDA.

Earlier this month, Solvay and Wyeth Pharmaceuticals received an action letter from the FDA informing them that bifeprunox is not approvable as a treatment for schizophrenia at the current time.

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