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Advisory Committee Meeting Scheduled for October 31, 2024; PDUFA Goal Date Remains December 20, 2024
Lexicon Seeks Approval for ZYNQUISTA™ (sotagliflozin) as an Adjunct to Insulin Therapy for Glycemic Control in Adults with Type 1 Diabetes and Chronic Kidney Disease
THE WOODLANDS, Texas, Aug. 21, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX), today announced that the U.S. Food and Drug Administration (FDA) expects to convene a meeting of the Endocrinologic and Metabolic Drugs Advisory Committee for Zynquista™ (sotagliflozin) as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes and chronic kidney disease (CKD) on October 31, 2024, with no change to the PDUFA goal date of December 20, 2024. According to the notice provided, the FDA intends to make the background materials available to the public no later than two business days before the meeting.
Posted In: LXRX