PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
PACKAGE LABEL BARICITINIB mg 30ct Bottle. Rx OnlyAlways Dispense With Medication GuideNDC 0002-6885-30baricitinibtablets4 mgFor use under Emergency Use Authorization (EUA).30 tabletsLilly. PACKAGE LABEL OLUMIANT mg 30ct Bottle.
SPL UNCLASSIFIED SECTION.
FACT SHEET FOR HEALTHCARE PROVIDERSEMERGENCY USE AUTHORIZATION (EUA) OF BARICITINIBThe U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of baricitinib for treatment of coronavirus disease 2019 (COVID-19) in hospitalized adults and pediatric patients years of age or older requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).Baricitinib has been authorized by FDA for the emergency uses described above. Baricitinib is not FDA-approved for these uses.Baricitinib is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of baricitinib under section 564(b)(1) of the Act, 21 U.S.C. 360bbb-3(b)(1), unless the declaration is terminated or authorization revoked sooner.