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Byetta FDA Approval History

FDA Approved: Yes (First approved April 28, 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 timeline 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

Further information

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