FDA approves single-dose propofol amid drug shortage

Editor's Note

The Food and Drug Administration (FDA) approved Amneal Pharmaceuticals' Abbreviated New Drug Application for single-dose vials of propofol injectable emulsion, Anesthesiology News August 23 reports. The newly approved formulations include 200 mg/20 mL, 500 mg/50 mL, and 1,000 mg/100 mL vials.

Propofol is widely used for anesthesia and sedation in hospitals and ambulatory surgery centers and is currently on the American Society of Health-System Pharmacists drug shortages list due to supply chain issues. Amneal plans to manufacture the drug in-house on a dedicated line to ensure a consistent supply and address the current shortage of this critical drug.

Amneal's executive vice president and chief commercial officer of Generics, Andy Boyer, emphasized the company’s focus on delivering drugs in short supply. “This single dose formulation of propofol is an essential medicine utilized every day…for surgical use. We are proud to provide our…customers with this hard-to-make product and help patients in need,” he told the outlet.

Propofol is contraindicated for individuals with known hypersensitivity to the drug, egg, or soybean. The company anticipates launching the product in the fourth quarter of 2024. According to IQVIA, US annual sales for propofol reached approximately $314 million for the 12 months ending in June 2024.