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FDA Sets Date for Decision on Salix Colonoscopy Prep Product

Posted June 22, 2006

— The Food and Drug Administration expects to make a decision about whether to approve a drug for use as a colonoscopy prep from

Salix Pharmaceuticals

by Aug. 2.

The FDA told Salix in April that manufacturing issues needed to be resolved before approval would be granted. In a statement Wednesday, Salix said it had worked with Norgine, the drug's European-based developer and producer, to resolve the FDA's concerns.

The drug, called MoviPrep, is intended for use as a bowel cleansing agent before a colonoscopy.

Salix said it expected the FDA to approve the drug and launch sales later this year.


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