Propofol 20mg/mL emulsion will be hereon allowed to be used as Emergency Use Authorization (EUA) in patients’ ≥16 years old that need mechanical ventilation in intensive care unit (ICU) during the COVID-19 pandemic, informed FDA. As this emulsion is not an approved product but it contains 2X concentration of the FDA-approved propofol 10mg/mL injection emulsion and poses to be at a risk of unintended overdose. Certain points to be kept in mind in accordance with the EUA of this emulsion are:

• Should be used to maintain sedation through continuous infusion in mechanically ventilated patients aged >16 years old.
• Should be administered only by a licensed healthcare provider (physicians, nurses, etc.) in an ICU.
• Should NOT be used in pregnancy, unless there are no FDA-approved products available for sedation in these patients should they need mechanical ventilation in an ICU setting.
• Specially be used in accordance with the dosing routines considering authorized Fact Sheets.

The EUA of this emulsion is based on the agency’s evaluation of available evidence regarding the efficacy of this drug in this situation. 

A multinational pharmaceutical company has also broadcasted the availability of Propofol Injectable Emulsion in 20mL, 50mL, and 100mL vials formulation in the US after approval of its additional Abbreviated New Drug Application.