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# Lexicon Refiles NDA for Sotagliflozin
- URL: https://www.fdaweb.com/lexicon-refiles-nda-for-sotagliflozin/
- Published: 2024-06-21T12:00:00.000Z
- Updated: 2026-09-14T14:33:53.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157227

Lexicon Pharmaceuticals says that after receiving recent FDA feedback it has resubmitted its NDA for sotagliflozin oral tablets, 200 milligrams (mg) and 400 mg, as an adjunct to insulin therapy in patients with Type 1 diabetes and chronic kidney disease (CKD). In 2021, CDER issued a *Federal Register* [*notice* ](https://www.govinfo.gov/content/pkg/FR-2021-03-03/pdf/2021-04342.pdf?ref=fdaweb.com)proposing to refuse to approve the NDA in its present form.

Sanofi-aventis, Lexicon’s predecessor-in-interest, submitted the original NDA 3/2018, and in 3/2019 CDER issued a complete response letter on the submission, 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.

“We are confident in the benefit/risk profile of sotagliflozin for people with Type 1 diabetes and CKD, and our team has been resolute in identifying and pursuing a regulatory path forward,” the company says. “The application remains in ‘filed’ status at the FDA and the company expects to receive a formal communication from FDA within 30 days of today’s submission establishing the action date and anticipates a six-month regulatory review period.”