Cellegy Cellegesic Receives FDA “Not Approvable” Letter
This article was originally published in The Pink Sheet Daily
Executive Summary
Issues relate to pivotal studies for Cellegesic, even though the company conducted a third Phase III trial under a special protocol agreement with FDA. The letter “raised several issues that were not part of the agreed upon approval criteria,” Cellegy claims.
You may also be interested in...
Cellegy Seeks A Buyer Or Partner For Cellegesic Following FDA “Approvable” Letter
"Approvable" letter indicates the need for additional studies to provide more evidence of the efficacy of the nitroglycerin ointment for anal fissures.
Cellegy Seeks A Buyer Or Partner For Cellegesic Following FDA “Approvable” Letter
"Approvable" letter indicates the need for additional studies to provide more evidence of the efficacy of the nitroglycerin ointment for anal fissures.
Cellegy’s Headache: FDA Says Analgesic Use May Have Skewed Cellegesic Efficacy Results
FDA advisory committee preview documents question whether concomitant acetaminophen use in trials of the nitroglycerin ointment could be responsible for a small reduction in anal fissure pain.