Glaxo Wellcome Lotronex
Executive Summary
Glaxo expects approval of the irritable bowel syndrome therapy in January, firm tells Chase H&Q conference Jan. 12, although the FDA review deadline has been extended by three months to March 31. FDA requested additional safety information after the Gastrointestinal Drugs Advisory Committee expressed concern over the incidence of constipation, possible cases of ischemic colitis and use in patients with elevated liver enzyme levels (1"The Pink Sheet" Nov. 22, 1999, p. 3)