Cellegy resubmits Cellegesic
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Cellegy is requesting a priority review for its June 30 resubmission of Cellegesic (nitrogylcerin ointment, 0.4%). The firm withdrew its NDA for the anal fissure therapy in April 2002 after disagreeing with FDA on statistical analyses in a pain reduction trial. Cellegy had projected resubmission by the third quarter after a special protocol assessment agreement for a confirmatory trial (1Pharmaceutical Approvals Monthly Sept. 1, 2003, p. 18). Cellegesic would be the first agent approved for anal fissures, which Cellegy says affect over 700,000 in the U.S...