08:47 AM EDT, 06/21/2024 (MT Newswires) -- Lexicon Pharmaceuticals ( LXRX ) said Friday that it has resubmitted its New Drug Application for sotagliflozin to supplement insulin therapy for persons with type 1 diabetes and chronic kidney disease, following multiple consultations with the US Food and Drug Administration.
The application remains in "filed" status at the FDA and the company expects receiving a formal communication from the FDA within 30 days after resubmission, a six-month regulatory review period, and a potential launch next year.