Diese Übersetzung wird noch vorbereitet. Bis dahin zeigen wir vorübergehend die englische Originalversion.
Geschäft · 3.3.20211 Min. Lesezeit
Proposal To Refuse To Approve a New Drug Application for Sotagliflozin Oral Tablets, 200 Milligrams and 400 Milligrams; Opportunity for a Hearing
Lokale automatische Übersetzung · Originalsprache der Quelle
Zusammenfassung
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.
Originalsprache der Quelle: Federal Register — Food and Drug AdministrationOriginalquelle öffnen →