Lexicon Announces Receipt of Complete Response Letter for Zynquista™ (sotagliflozin)
Lexicon Pharmaceuticals(LXRX) Newsfilter·2024-12-20 21:30
THE WOODLANDS, Texas, Dec. 20, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX) today announced it has received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for Zynquista™ (sotagliflozin) as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes and chronic kidney disease (CKD). This expected communication from the FDA aligns with the company's previously disclosed strategic decision ...