* Solvay's Creon can remain on the market
* Creon only such approved drug on U.S. market
WASHINGTON, - U.S. health officials have formally approved Solvay SA's (SOLB.BR) enzyme drug Creon for adults and children with a digestive disorder resulting from conditions such as cystic fibrosis and chronic pancreatitis, the agency said on Friday.
The drug, also known by its generic name pancrelipase, treats exocrine pancreatic insufficiency, in which patients lack enzymes from the pancreas that are essential to digesting food.
Solvay Pharmaceuticals, a unit of Brussels-based Solvay SA, had been seeking FDA approval to continue to sell Creon, which is made from pig glands.
Creon and related drugs have been on the market for so long that they were never required to undergo FDA approval. But in 2004 the agency ordered companies to prove such drugs were safe and effective amid concerns that they may transmit various viruses such as influenza and hepatitis to humans.
Solvay has said it takes steps to minimize the risk of infection in manufacturing Creon, and so far it has not seen a pattern of illness. An FDA panel of outside experts in December 2008 also said there was no evidence of risk to patients.
The most common side effects in patients taking Creon include gas and upset stomach, according to the FDA. More serious risk includes a possible rare bowel disorder, known as fibrosing colonopathy, that could require surgery.
Companies selling such enzyme products have until April 2010 to win U.S. approval or else halt sales.
Other manufacturers of pig-based pancreatic enzyme drugs include K-V Pharmaceutical Co (KVa.N) unit Ethex Corp and privately-held Axcan Pharma Inc, among others. Some rivals also make versions derived from vegetables and cows.
Altus Pharmaceuticals Inc (ALTU.O) is developing a rival drug produced from microbes. (Reporting by Susan Heavey; Editing by Tim Dobbyn)
