Amylin Pharmaceuticals, Inc. , Eli Lilly and Company  and Alkermes, Inc. announced that the FDA  has acknowledged the companies’ BYDUREON™ (exenatide extended-release for injectable suspension) resubmission. The FDA has categorized it as a Class 2 resubmission requiring up to six months for review and assigned a new Prescription Drug User Fee Act (PDUFA) action date of January 28, 2012

BYDUREON is the proposed brand name for exenatide extended-release for injectable suspension. It is designed to deliver continuous therapeutic levels of exenatide in a single weekly dose. BYDUREON is a once-weekly formulation of exenatide, the active ingredient in BYETTA®  (exenatide) injection, which has been available in the U.S. since June 2005 and is used in more than 70 countries worldwide to improve glycemic control in adults with type 2 diabetes. BYDUREON and BYETTA belong to the glucagon-like peptide-1 (GLP-1) receptor agonist class of medications.