Diese Übersetzung wird noch vorbereitet. Bis dahin zeigen wir vorübergehend die englische Originalversion.
Geschäft · 12.9.20141 Min. Lesezeit
MK Laboratories, Inc., et al.; Withdrawal of Approval of 3 Abbreviated New Drug Applications for Propoxyphene Products
Lokale automatische Übersetzung · Originalsprache der Quelle
Zusammenfassung
The Food and Drug Administration (FDA) is withdrawing approval of three abbreviated new drug applications (ANDAs) for products containing propoxyphene. The basis for the withdrawals is that the products are no longer shown to be safe because propoxyphene puts patients at risk of potentially serious and even fatal heart rhythm abnormalities. The holders of these ANDAs have waived their opportunity for a hearing.
Originalsprache der Quelle: Federal Register — Food and Drug AdministrationOriginalquelle öffnen →