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Soliqua 100/33 FDA Approval History

FDA Approved: Yes (First approved November 21, 2016)
Brand name: Soliqua 100/33
Generic name: insulin glargine and lixisenatide
Dosage form: Injection
Company: Sanofi
Treatment for: Diabetes, Type 2

Soliqua 100/33 (insulin glargine and lixisenatide) is fixed-ratio combination of the long-acting human insulin analog insulin glargine (Lantus) and the glucagon-like peptide-1 (GLP-1) receptor agonist lixisenatide (Adlyxin), indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

Development Timeline for Soliqua 100/33

DateArticle
Feb 27, 2019Approval FDA Expands Indication for Soliqua 100/33 (insulin glargine and lixisenatide injection) to Include Type 2 Diabetes Patients Uncontrolled on Oral Antidiabetic Medicines
Nov 21, 2016Approval Sanofi Receives FDA Approval of Soliqua 100/33 (insulin glargine and lixisenatide) for the Treatment of Adults with Type 2 Diabetes
Aug 20, 2016Zealand Announces New Timelines for a U.S. FDA Decision on iGlarLixi, the Fixed-Ratio Combination of Lixisenatide (Adlyxin) and Lantus, for the Treatment of Type 2 Diabetes
May 25, 2016FDA Advisory Committee Recommends Approval of Sanofi Treatment for Adults With Type 2 Diabetes
Feb 22, 2016FDA Accepts Sanofi NDA for Once-Daily Fixed-Ratio Combination of Insulin Glargine and Lixisenatide
Dec 23, 2015Sanofi Submits NDA for Once-Daily Fixed-Ratio Combination of Insulin Glargine and Lixisenatide

Further information

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