Amylin Pharmaceuticals, Inc., (AMLN) Eli Lilly and Co., (LLY) announced that they received approval from the U.S. Food and Drug Administration or FDA for an expanded indication for BYETTA injection.
The new approval is for using BYETTAs a stand-alone medication 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 approved changes to the BYETTA Prescribing Information to incorporate updated safety information, including pancreatitis-related language added to the Warnings and Precautions section.
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