> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# CDER Hearing Delay on NDA is ‘Unfounded’: Lexicon
- URL: https://www.fdaweb.com/cder-hearing-delay-on-nda-is-unfounded-lexicon/
- Published: 2022-11-29T12:00:00.000Z
- Updated: 2026-09-14T18:07:51.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153276

Lexicon Pharmaceuticals says a CDER proposed order to delay a hearing and deny approval of the company’s NDA for sotagliflozin oral tablets to treat Type 1 diabetes mellitus (T1DM) “is unfounded based on the facts of the data presented by Lexicon: an effective drug for TIDM, with additional efficacy benefits in terms of weight and blood pressure reduction, is being denied on the basis of a DKA (diabetic ketoacidosis) that can be mitigated and managed through a REMS and other measures that healthcare providers and patients are already familiar with and utilizing.” Lexicon’s position is stated in its 11/28 [response](https://downloads.regulations.gov/FDA-2021-N-0208-0091/attachment%5F1.pdf?ref=fdaweb.com) to the proposed CDER order.

The company says that for a patient population with limited treatment options other than injectable insulin, “sotagliflozin would provide another option in the armamentarium of managing a chronic and burdensome disease.”

Lexicon asks that its NDA for the 200 mg dose be approved with a REMS or a hearing be scheduled to resolve the “numerous genuine and substantial issues of fact regarding the approval of” the NDA.