OTC sucralfate/H2 blocker/antacid combos get FDA go-ahead for clinical trials.
This article was originally published in The Tan Sheet
Executive Summary
OTC SUCRALFATE/H2 BLOCKER/ANTACID COMBOS CLINICAL TRIALS CLEARED by FDA, sponsor Ashley Downs Pharmaceutical announced. Investigational New Drug application #51,622 is for liquid sucralfate/magaldrate, called Sucralate or Sucrate; IND #51,623 is for chewable sucralfate/calcium carbonate (Caralox); and IND #51,624 is for chewable sucralfate/calcium carbonate/ranitidine (unnamed). The company plans to seek OTC approval for treatment of heartburn.