The U.S. Food and Drug Administration (FDA) has approved the SymlinPen120 and the SymlinPen60 pen-injector devices for injecting pramlintide acetate, manufacturer Amylin Pharmaceuticals, Inc. has announced.
Symlin is approved in the US for patients suffering from type 2 or type 1 diabetes, who require insulin before mealtime in order to control their glucose levels.
SymlinPen 60 has got fixed dosing feature that allows for delivery of 15, 30, 45, or 60 micrograms per dose, while SymlinPen 120 allows for 60 or 120 micrograms per dose. Amylin said both devices must be stored at temperatures not exceeding 86 degrees F (30 degrees C) after they are first used.
"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."
Amylin also revealed that the FDA had issued a "Not Approvable" letter for a proposal to use Symlin with basal insulin alone.
