Oct 1 Amylin Pharmaceuticals Inc AMLN.O said
U.S. health regulators issued a "not approvable" letter for
Symlin use without mealtime insulin in patients with type 2
diabetes who have not achieved desired glucose control.
The Food and Drug Administration has approved SymlinPen 120
and SymlinPen 60 pen-injector devices to administer Symlin
injection to improve mealtime glucose control, the San
Diego-based biotechnology company said in a statement.
Symlin is currently approved in the United States for
patients with type 2 or type 1 diabetes who use mealtime
insulin and need improved glucose control.
(Reporting by Bhaswati Mukhopadhyay in Bangalore)