Amneal’s Propofol Injectable Emulsion in single dose vials given approval by FDA
Amneal has received the Food and Drug Administration’s permission for Propofol Injectable Emulsion, 200 mg/20 ml (10 mg/ml), 500 mg/50 ml (10 mg/ml) and 1,000 mg/100 mL (10 mg/ml), Single-Dose Vials.
Propofol is an intravenous drug commonly used in hospitals for the induction and maintenance of anesthesia and sedation. It is currently on the American Society of Health System Pharmacists drug shortages list.
[Related: Amneal touts 39 retail, injectable product launches in 2023]
Propofol has a history of shortage due to supply chain constraints. The company said it will manufacture the product in-house on a dedicated line to provide consistent supply and expects to launch propofol in the fourth quarter of 2024.
“Amneal is keenly focused on delivering critical drugs that are in short supply,” said Andy Boyer, executive vice president, chief commercial officer of generics at Amneal. “This single dose formulation of propofol is an essential medicine utilized every day by hospitals for surgical use. We are proud to provide our hospital customers with this hard-to-make product and help patients in need. With our large global manufacturing footprint, Amneal aims to be the provider of choice for complex products like propofol.”
[Read more: Amneal expands injectables portfolio with 6 new therapies]
Propofol had a market value of roughly $314 million for the 12 months ended June 2024, per IQVIA.