Table 2.
Date of first issuance | Treatment | Authorized use |
---|---|---|
22-Jun-10 | Antivirals: oseltamivir (Tamiflu), zanamivir (Relenza), and peramivir | To treat and prevent 2009 H1N1 influenza |
09-Jul-18 | Pathogen-reduced leukocyte-depleted freeze-dried plasma | For the treatment of hemorrhage or coagulopathy during an emergency involving agents of military combat (e.g., firearms, projectiles, and explosive devices) when plasma is not available for use or when the use of plasma is not practical |
30-Apr-20 | Fresenius Medical, multiFriltrate PRO System and multiBic/multiPlus solutions | To provide CRRT to treat patients in an acute care environment during the COVID-19 pandemic |
01-May-20 | Remdesivir for certain hospitalized COVID-19 patients | For the treatment of suspected or laboratory-confirmed COVID-19 in hospitalized pediatric patients weighing 3.5 kg to < 40 kg or hospitalized pediatric patients aged < 12 years weighing at least 3.5 kg |
08-May-20 | Fresenius Kani Propoven 2% | To maintain sedation via continuous infusion in patients aged > 16 with suspected or confirmed COVID-19 who require mechanical ventilation in an ICU setting |
13-Aug-20 | REGIOCIT replacement solution that contains citrate for RCA of the extracorporeal circuit | To be used as a replacement solution only in adult patients treated with CRRT, and for whom regional citrate anticoagulation is appropriate, in a critical care setting |
23-Aug-20 | COVID-19 convalescent plasma | For the treatment of hospitalized patients with COVID-19 |
09-Nov-20 | Bamlanivimab | For the treatment of mild-to-moderate COVID-19 in adult and pediatric patients with positive results of direct SARS-CoV-2 viral testing who are aged ≥ 12 years weighing at least 40 kg (about 88 pounds), and who are at high risk for progressing to severe COVID-19 and/or hospitalization |
19-Nov-20 | Baricitinib (Olumiant) in combination with remdesivir (Veklury) | For the treatment of suspected or laboratory-confirmed COVID-19 in hospitalized adults and pediatric patients aged ≥ 2 years requiring supplemental oxygen, invasive mechanical ventilation, or ECMO |
21-Nov-20 | Casirivimab and imdevimab | To be administered together for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (aged ≥ 12 years weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progressing to severe COVID-19 and/or hospitalization |
09-Feb-21 | Bamlanivimab and estesevimab | For the treatment of mild-to-moderate COVID-19 in adult and pediatric patients with positive results of direct SARS-CoV-2 viral testing who are aged ≥ 12 years weighing at least 40 kg (about 88 pounds), and who are at high risk for progressing to severe COVID-19 and/or hospitalization |
12-Mar-21 | Propofol-Lipuro 1% | To maintain sedation via continuous infusion in patients greater than age 16 with suspected or confirmed COVID-19 who require mechanical ventilation in an ICU setting |
COVID-19 Coronavirus Disease 2019, CRRT continuous renal replacement therapy, ECMO extracorporeal membrane oxygenation, EUA Emergency Use Authorization, ICU intensive care unit, RCA regional citrate anticoagulation