Amylin Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved the SymlinPen(TM) 120 and the SymlinPen(TM) 60 pen-injector devices for administering SYMLIN(R) (pramlintide acetate) injection.
These new pre-filled pen-injector devices feature simple, fixed dosing to improve mealtime glucose control.
“SymlinPen 120 and SymlinPen 60 offer patients improved convenience and accuracy,” said Daniel M. Bradbury, President and CEO, Amylin Pharmaceuticals. “For people with diabetes using mealtime insulin, the addition of SYMLIN can enhance glucose control with the potential for weight loss.”
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.
“SYMLIN remains an important therapeutic option for people with diabetes who use mealtime insulin therapy,” Bradbury added. “We will initiate discussions with the FDA to clarify their response for its use with basal insulin alone.”