FDA Sets Date for Decision on Salix Colonoscopy Prep Product
Posted June 22, 2006
RALEIGH, N.C. — The Food and Drug Administration expects to make a decision about whether to approve a drug for use as a colonoscopy prep from
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.