Bydureon Approval History

• FDA approved: Yes (First approved January 27th, 2012)
• Brand name: Bydureon
• Generic name: exenatide
• Company: Amylin Pharmaceuticals, Inc. and Alkermes plc
• Treatment for: Diabetes, Type 2

Bydureon (exenatide) is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

FDA Approval History for Bydureon

Date	Article
Jan 27, 2012	FDA Approves Bydureon - The First and Only Once-Weekly Treatment for Type 2 Diabetes
Aug 10, 2011	Bydureon FDA Action Date Set for January 28, 2012
Jul 28, 2011	Bydureon Reply Submitted to FDA
Oct 20, 2010	Amylin, Lilly and Alkermes Announce Receipt of Complete Response Letter from FDA for Bydureon
May  6, 2010	Bydureon FDA Review Timeline Set with PDUFA Action Date of October 22, 2010
Apr 23, 2010	Amylin, Lilly and Alkermes Submit Reply to FDA Complete Response Letter for Bydureon

See also...

Bydureon (exenatide) Consumer Information

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