US FDA panel: Virus screening OK for Solvay drug

Tue Dec 2, 2008 3:06pm EST
 
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SILVER SPRING, Md., Dec 2 (Reuters) - Solvay Pharmaceuticals Inc does not need to develop additional tests to screen out three new viruses that may be carried in pig proteins used to make its pancreatic enzyme drug Creon, a U.S. advisory panel said on Tuesday.

In a 10-to-6 vote, the U.S. Food and Drug Administration panel of outside advisers said more tests were not warranted because it was unclear whether people taking the enzymes were at risk for the three viruses -- porcine parvovirus, and two types of porcine circovirus.

Solvay Pharmaceuticals, a unit of Brussels-based Solvay SA (SOLB.BR), is seeking FDA approval to continue to sell its Creon capsules in the United States for patients with exocrine pancreatic insufficiency.

(Reporting by Susan Heavey)

 

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