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FDA Approves Symlin Pen, But Forbids Symlin Use Without Bolus Insulin

The Food and Drug Administration (FDA) just approved pre-filled pens for administering Symlin, which was previously available only in vials. The SymlinPen 60 delivers 15, 30, 45, or 60 micrograms per dose.

The SymlinPen 120 delivers 60 or 120 micrograms per dose. Both may be stored at room temperature, up to 86 degrees, after first use.

The FDA also issued a “Not Approvable” letter forbidding the use of Symlin in patients with type 2 who are using basal insulin but are not using meal-time, or bolus, insulin. Symlin is approved for use only in type 1s or type 2s who are using meal-time boluses and need more help with their blood sugar control.

Source: Amylin Press Release, September 2007

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