FDA approves labeling supplement for Lexicon's INPEFA (sotagliflozin)
The agency signed off on a third supplement to INPEFA's original approval, updating the drug's label and medication guide.
Lexicon Pharmaceuticals had one regulatory action this week.
- A labeling supplement (submission number 3) for INPEFA, the brand name for sotagliflozin, was approved by the FDA, with an approval letter dated August 10, 2026 and an updated label and medication guide dated August 11, 2026.1 INPEFA is available as an oral tablet in 400MG and 200MG strengths of sotagliflozin.1
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