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# Lexicon Pharma Seeks Hearing on Sotagliflozin Rejection
- URL: https://www.fdaweb.com/lexicon-pharma-seeks-hearing-on-sotagliflozin-rejection/
- Published: 2021-03-03T12:00:00.000Z
- Updated: 2026-09-14T16:49:22.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5148789

*Federal Register* notice: CDER is proposing to refuse to approve a Lexicon Pharmaceuticals NDA for sotagliflozin oral tablets, 200 milligrams (mg) and 400 mg, in its present form. The notice summarizes the grounds for the Center’s proposal and offers Lexicon an opportunity to request a hearing. Sanofi-aventis, Lexicon’s predecessor-in-interest, submitted the NDA 3/2018 seeking an indication as an adjunct to insulin therapy to improve glycemic control in adults with Type 1 diabetes mellitus. In 3/2019, CDER issued a complete response letter to Sanofi stating that the NDA could not be approved in its present form. It cited deficiencies such as the data demonstrated 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 the determination that the drug’s DKA risk outweighed its benefits. Lexicon has now requested an opportunity for a hearing and this notice is in response to that. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2021-03-03/pdf/2021-04342.pdf?ref=fdaweb.com).