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# FDA Accepts Lexicon NDA for Resubmitted Diabetes Drug
- URL: https://www.fdaweb.com/fda-accepts-lexicon-nda-for-resubmitted-diabetes-drug/
- Published: 2024-07-16T12:00:00.000Z
- Updated: 2026-09-14T14:35:34.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157358

FDA has accepted for review a resubmitted Lexicon Pharmaceuticals NDA for Zynquista (sotagliflozin) as an adjunct to insulin therapy for glycemic control in adults with Type 1 diabetes and chronic kidney disease (CKD). The agency indicated that it considers the resubmission to be a complete response to its 2019 complete response letter. FDA has set a 12/20 user fee review action target date.

Sanofi-aventis, Lexicon’s predecessor-in-interest, submitted the original NDA 3/2018, and in 3/2019 CDER issued a complete response letter, citing deficiencies such as data demonstrating that the addition of sotagliflozin to insulin is associated with an increased risk of diabetic ketoacidosis (DKA), a serious and often life-threatening consequence of insulin insufficiency. Two subsequent dispute resolution requests were rejected by CDER based on a determination that the drug’s DKA risk outweighed its benefits.