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Source: http://www.reuters.com/article/rbssIndustryMaterialsUtilitiesNews/idUSWAT01058620081128
Virus concerns linger for Solvay enzyme drug - FDA
Fri Nov 28, 2008 9:41am EST
WASHINGTON, Nov 28 (Reuters) - The risk of contracting viruses from pig glands used to make Solvay Pharmaceuticals Inc's pancreatic enzyme drug Creon must be lowered, U.S. Food and Drug Administration staff said in documents released on Friday.
"Given the occurrence of these viruses in European and U.S. sourced swine, we believe that the risk associated from the use of Creon should be reduced," several staff members wrote.
The FDA released the documents ahead of a Dec. 2 advisory committee meeting to discuss whether to approve Creon. While the agency will make the final decision, it often follows recommendations from its outside advisers.
The drugmaker, a unit of Brussels-based Solvay SA (SOLB.BR: Quote, Profile, Research, Stock Buzz). (Reporting by Susan Heavey, editing by Gerald E. McCormick)
Virus concerns linger for Solvay enzyme drug - FDA
Fri Nov 28, 2008 9:41am EST
WASHINGTON, Nov 28 (Reuters) - The risk of contracting viruses from pig glands used to make Solvay Pharmaceuticals Inc's pancreatic enzyme drug Creon must be lowered, U.S. Food and Drug Administration staff said in documents released on Friday.
"Given the occurrence of these viruses in European and U.S. sourced swine, we believe that the risk associated from the use of Creon should be reduced," several staff members wrote.
The FDA released the documents ahead of a Dec. 2 advisory committee meeting to discuss whether to approve Creon. While the agency will make the final decision, it often follows recommendations from its outside advisers.
The drugmaker, a unit of Brussels-based Solvay SA (SOLB.BR: Quote, Profile, Research, Stock Buzz). (Reporting by Susan Heavey, editing by Gerald E. McCormick)