Marion Merrell Dow's Carafate suspension
This article was originally published in The Tan Sheet
Executive Summary
Rx product is approved Dec. 16 after a 10-year review at FDA. The NDA for sucralfate was the subject of 30 amendments while pending at the agency. The indication for the liquid. formulation is for short-term (up to eight weeks) treatment of active duodenal ulcer. Carafate (sucralfate) 1 g tablets are indicated for short-term and maintenance therapy. MMD said that the suspension will provide an alternative for those who have trouble taking tablets. Carafate has been mentioned as a potential candidate for future Rx-to-OTC switch.