Proposal To Refuse To Approve a New Drug Application for Sotagliflozin Oral Tablets, 200 Milligrams and 400 Milligrams; Opportunity for a Hearing

摘要

The Director of the Center for Drug Evaluation and Research (Center Director) of the Food and Drug Administration (FDA or Agency) is proposing to refuse to approve a new drug application (NDA) submitted by Lexicon Pharmaceuticals, Inc. (Lexicon) for sotagliflozin oral tablets, 200 milligrams (mg) and 400 mg, in its present form. This notice summarizes the grounds for the Center Director's proposal and offers Lexicon an opportunity to request a hearing on the matter.