Lexicon Pharmaceuticals Receives December 20, 2024 PDUFA Goal Date for Sotagliflozin Type 1 Diabetes NDA Resubmission

July 16, 2024

Lexicon Pharmaceuticals announced the FDA acknowledged the resubmission of its NDA for Zynquista (sotagliflozin) for type 1 diabetes and CKD, with a PDUFA goal date of December 20, 2024.

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chronic kidney disease (CKD)Type 1 Diabetes Type 1 Diabetes U.S. Food and Drug Administration sotagliflozin chronic kidney disease Zynquista Lexicon Pharmaceuticals sotagliflozin U.S. Food and Drug Administration (FDA)Lexicon Pharmaceuticals

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Lexicon Pharmaceuticals Resubmits Sotagliflozin NDA for Type 1 Diabetes

Lexicon Pharmaceuticals resubmits sotagliflozin NDA for type 1 diabetes and CKD, aiming to provide an adjunct to insulin therapy for glycemic control. The company is optimistic about the benefit/risk profile and expects a six-month regulatory review period.

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Lexicon Pharmaceuticals Receives December 20, 2024 PDUFA Goal Date for Sotagliflozin Type 1 Diabetes NDA Resubmission

Lexicon Pharmaceuticals announced the FDA acknowledged the resubmission of its NDA for Zynquista (sotagliflozin) for type 1 diabetes and CKD, with a PDUFA goal date of December 20, 2024.