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Byetta Approval History

  • FDA approved: Yes (First approved April 28th, 2005)
  • Brand name: Byetta
  • Generic name: exenatide
  • Dosage form: Injection
  • Company: Amylin Pharmaceuticals / Eli Lilly & Co.
  • Treatment for: Diabetes, Type 2

Byetta (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 mellitus.

Development History and FDA Approval Process for Byetta

Oct 20, 2011Approval Byetta Approved for Use with Insulin Glargine in the U.S.
Nov  2, 2009Approval Byetta Approved for Expanded Use as First-Line Treatment for Type 2 Diabetes
Apr 28, 2005Approval Byetta Amylin Pharmaceuticals / Eli Lilly & Co. - Treatment for Type 2 Diabetes
Sep  1, 2004Exenatide New Drug Application Accepted for Review by the FDA
Jun 30, 2004New Drug Application for Exenatide Submitted to FDA for Type 2 Diabetes

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