The FDA has approved an expanded indication for Amylin Pharmaceuticals and Eli Lilly’s Byetta (exenatide) injection for use as a stand-alone medication (monotherapy) along with diet and exercise, to improve glycemic control in adults with type 2 diabetes.
Previously, it was approved for use only in patients who were also taking other common diabetes medications and had not achieved adequate glycemic control.
In addition to the monotherapy indication, the FDA changed Byetta's prescribing information to incorporate updated safety information, including pancreatitis-related language added to the warnings and precautions section. The update addresses the alert issued by the FDA in August 2008. The new label also expands upon existing language regarding use of Byetta in patients with renal impairment.