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Lexicon Pharmaceuticals Resubmits New Drug Application for Potential Type 1 Diabetes Therapy
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Lexicon Pharmaceuticals Resubmits New Drug Application for Potential Type 1 Diabetes Therapy
Jun 21, 2024 6:12 AM

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.

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