Local News

FDA Sets Date for Decision on Salix Colonoscopy Prep Product

Posted Updated

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

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.

Copyright 2024 by Capitol Broadcasting Company. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.