Symlin Approval In Riskier Type 1 Diabetes Prompted By Off-Label Dangers – FDA
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Approval of Amylin’s Symlin for both type 1 and type 2 diabetes, despite a higher risk of severe hypoglycemia in type 1 patients, was prompted by FDA concerns over potential off-label use for type 1 disease, agency review documents show.