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Adlyxin FDA Approval History

FDA Approved: Yes (First approved July 27, 2016)
Brand name: Adlyxin
Generic name: lixisenatide
Dosage form: Injection
Company: Sanofi
Treatment for: Diabetes, Type 2

Adlyxin (lixisenatide) is a once-daily prandial GLP-1 receptor agonist for the treatment of adults with type 2 diabetes mellitus.

Development timeline for Adlyxin

Jul 27, 2016Approval Sanofi Receives FDA Approval of Adlyxin (lixisenatide) for Treatment of Adults With Type 2 Diabetes
Sep 29, 2015Sanofi New Drug Application for Lixisenatide Accepted for Review by FDA
Sep 14, 2015Sanofi Reports Positive Top-Line Results In Second Pivotal Lixilan Phase III Study
Jun  8, 2015Sanofi's Lyxumia (lixisenatide) Demonstrated Cardiovascular Safety in People With Type 2 Diabetes and High CV Risk
Jun  6, 2015Lyxumia (Lixisenatide) Meets Co-Primary Endpoints in GetGoal Duo-2 Trial
Mar 19, 2015Sanofi Announces Top-Line Results for Cardiovascular Outcomes Study of Lyxumia (Lixisenatide)
Jun 14, 2014Sanofi's Lyxumia (lixisenatide) Showed More Pronounced After-Test-Meal Blood Sugar Lowering than Liraglutide when Both were Added to Insulin Glargine
Sep 12, 2013Sanofi Provides Update on Lixisenatide New Drug Application in U.S.
Feb 19, 2013Sanofi New Drug Application for Lixisenatide Accepted for Review by FDA

Further information

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