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Bydureon Approval History

  • FDA approved: Yes (First approved January 27th, 2012)
  • Brand name: Bydureon
  • Generic name: exenatide
  • Dosage form: Extended-Release Injectable Suspension
  • 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.

Development History and FDA Approval Process for Bydureon

Mar  3, 2014Approval FDA Approves Bydureon Pen for Once-Weekly Treatment of Adults with Type 2 Diabetes
Jan 27, 2012Approval FDA Approves Bydureon - The First and Only Once-Weekly Treatment for Type 2 Diabetes
Aug 10, 2011Bydureon FDA Action Date Set for January 28, 2012
Jul 28, 2011Bydureon Reply Submitted to FDA
Oct 20, 2010Amylin, Lilly and Alkermes Announce Receipt of Complete Response Letter from FDA for Bydureon
May  6, 2010Bydureon FDA Review Timeline Set with PDUFA Action Date of October 22, 2010
Apr 23, 2010Amylin, Lilly and Alkermes Submit Reply to FDA Complete Response Letter for Bydureon

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