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Amylin says Symlin use without mealtime insulin not approvable

Mon Oct 1, 2007 7:34am EDT

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Oct 1 (Reuters) - 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.

Regulatory News

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)

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