FDA approval has been given to Amylin Pharmaceuticals, Inc. to market their automatic Symlin injection devices. Symlin (pramlintide), a synthetic analog of human amylin, a naturally occurring neuroendocrine hormone, is the first of its kind injected antihyperglycemic medication for use in patients with type 2 or type 1 diabetes. Two versions, rated by their maximum dosage, should be available for purchase in December.
SymlinPen(TM) 60 features fixed dosing to deliver 15, 30, 45, or 60 micrograms per dose. SymlinPen(TM) 120 features fixed dosing to deliver 60 or 120 micrograms per dose. Both pen-injector devices can be conveniently stored at room temperature not to exceed 86 degrees F (30 degrees C) after first use. The pens are expected to be available to patients by December 2007.
“Not Approvable” Letter Received for SYMLIN Use with Basal Insulin Alone
Amylin also announced today that the FDA has issued a “Not Approvable” letter for SYMLIN use with basal insulin (without mealtime insulin) in patients with type 2 diabetes who have not achieved desired glucose control. SYMLIN is currently approved in the U.S. for patients with type 2 or type 1 diabetes who use mealtime insulin and need improved glucose control.
Press release: Amylin Pharmaceuticals, Inc. Says SYMLIN Pen-Injector Devices Use Without Mealtime Insulin Not Approvable
Official Symlin information page…
