Amylin Pharmaceuticals, Inc., of San Diego, announced the approval the SymlinPen 120 and the SymlinPen 60 pre-filled pen-injector devices for administering Symlin (pramlintide acetate) to improve mealtime glucose control.
SymlinPen 60 features fixed dosing to deliver 15, 30, 45, or 60 mcg per dose, while SymlinPen 120 features fixed dosing to deliver 60 or 120 mcg per dose. Both devices can be conveniently stored at room temperature after first use.
“SymlinPen 120 and SymlinPen 60 offer patients improved convenience and accuracy,” said Daniel M. Bradbury, president and CEO of Amylin. The SymlinPens are expected to be available to patients by December. Amylin also announced 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 glucose control goals.
The drug is approved in the United States for improving glucose control in patients with type 1 or 2 diabetes who use mealtime insulin.