Amylin Symlin "approvable" Oct. 10
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
FDA deems Amylin's antidiabetic agent Symlin (pramlintide) "approvable" Oct. 10. The firm says it will conduct additional trials, which may focus on dose titration. At a July 26 FDA Endocrinologic and Metabolic Drugs Advisory Committee meeting, the company said it was planning a six-week Symlin safety study to evaluate the increased incidence of hypoglycemia associated with the agent. The committee voted during the meeting that there was insufficient data to define Symlin's safety profile