Hikma Pharmaceuticals PLC (Hikma, Group), the multinational pharmaceutical company, announces the launch of Propofol Injectable Emulsion, USP, 20 mL, 50 mL and 100 mL Vials, in the United States through its US affiliate, Hikma Pharmaceuticals USA Inc., following approval of its supplemental Abbreviated New Drug Application by the U.S. Food and Drug Administration (FDA).

Propofol Injectable Emulsion is indicated for the initiation and maintenance of sedation and anesthesia, including for intubated, mechanically ventilated adults in the Intensive Care Unit. It is currently on the FDA's Drug Shortage List, following a surge in demand due to the increase in hospitalized, ventilated patients resulting from the COVID-19 pandemic.

In order to get needed supplies to patients as quickly as possible, Hikma is launching with available, limited quantities of its 20 mL and 100 mL vials, with 50 mL vials to follow shortly thereafter. The company is working quickly to scale up manufacturing and will continue releasing product as soon as it is available.

"The launch of Propofol is the latest example of Hikma's ongoing, company-wide commitment to delivering essential medicines to our customers and their patients during this critical time," said Riad Mishlawi, President of Injectables, Hikma. "We have focused our strong US and global manufacturing capabilities on producing medicines that are in highest demand due to the outbreak of COVID-19 including anaesthetics, pain medicines, sedatives, neuromuscular blocking agents, anti-infectives and other support medications. We are grateful to the FDA for their timely approval of our application for Propofol Injection and look forward to delivering this needed medicine to hospitals and patients."