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FDA Sets PDUFA Goal Date for Lexicon Pharmaceuticals' NDA Resubmission for Sotagliflozin
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FDA Sets PDUFA Goal Date for Lexicon Pharmaceuticals' NDA Resubmission for Sotagliflozin
Jul 16, 2024 6:20 AM

08:51 AM EDT, 07/16/2024 (MT Newswires) -- Lexicon Pharmaceuticals ( LXRX ) said Tuesday the US Food and Drug Administration has set a Prescription Drug User Fee Act goal date of Dec. 20 for Zynquista as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes and chronic kidney disease.

The company said the FDA indicated that it considers the resubmission to be a complete response to the regulator's action letter in 2019 regarding the sotagliflozin NDA for type 1 diabetes.

"With a PDUFA date now in hand, we can begin the next phase of launch preparation for Zynquista," Chief Executive Mike Exton said in a statement.

Price: 2.0700, Change: -0.05, Percent Change: -2.36

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