FDAnews
www.fdanews.com/articles/87739-first-horizon-s-glycopyrrolate-granted-orphan-drug-status

FIRST HORIZON'S GLYCOPYRROLATE GRANTED ORPHAN-DRUG STATUS

June 20, 2006

The FDA has granted orphan-drug status to First Horizon Pharmaceutical's glycopyrrolate, which is used to treat chronic moderate-to-severe drooling in pediatric patients. This condition often results from cerebral palsy and other neurological disorders. The company is currently conducting clinical trials for this indication.

Glycopyrrolate, an anticholinergic agent, also is approved as an adjunctive therapy in the treatment of peptic ulcers.