BN Business News
Add your company to Business Communicator →

Business · 03/03/2021Updated: 10/17/2026 · 1 min read

FDA Director Proposes to Refuse Approval of Lexicon's Sotagliflozin Drug Application

The FDA Director is proposing to reject Lexicon Pharmaceuticals' new drug application for sotagliflozin oral tablets due to concerns, and is offering the company the chance to request a hearing on the matter.

Original source language: Federal Register — Food and Drug AdministrationOpen original release →

Explore insights

Business insights →