Amylin Symlin Study Will Evaluate Hypoglycemia Risk During Dose Initiation
Executive Summary
Amylin is planning a six-week Symlin safety study to evaluate the increased incidence of hypoglycemia associated with the antidiabetic agent, the company said following a July 26 FDA advisory committee recommendation against approval of the drug.
You may also be interested in...
Amylin Agrees To Symlin Marketing Restrictions In Gaining FDA Approval
Amylin has agreed to a ban on direct-to-consumer advertising and other marketing restrictions for its diabetes therapy Symlin (pramlintide) as part of FDA's March 16 approval of the drug
Amylin Agrees To Symlin Marketing Restrictions In Gaining FDA Approval
Amylin has agreed to a ban on direct-to-consumer advertising and other marketing restrictions for its diabetes therapy Symlin (pramlintide) as part of FDA's March 16 approval of the drug
Symlin “Approvable” Letter Will Be Addressed By Ongoing Trials, Amylin Says
Amylin hopes that data from two ongoing open-label Symlin trials will address questions outlined by FDA in an "approvable" letter for the diabetes agent