Posted by Michael Wonder on 01 Mar 2022
Lexicon voluntarily withdraws sotagliflozin new drug application and plans prompt resubmission targeted early Q2 2022
28 February 2022 - Resubmission to Correct Recently-Identified Technical Issue.
Lexicon Pharmaceuticals today announced the voluntary withdrawal and planned near-term resubmission of the company’s New Drug Application (NDA) for sotagliflozin to correct a technical issue with the submission recently identified by the company. The company promptly notified the U.S. Food and Drug Administration (FDA) about the issue and has been in discussions with the agency to correct the submission. Due to the proximity to the conclusion of the 60-day filing review period, Lexicon determined, after consultation with the FDA, that the withdrawal of the NDA and a subsequent resubmission would be the most appropriate action to provide a complete submission for review.
