Propofol Injectable Emulsion Single-Dose Vials Receive FDA Approval

Propofol injectable emulsion USP, 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 (Amneal) received FDA approval, increasing access to surgical anesthetics for clinicians and care centers.¹

Propofol is contraindicated for patients with any allergies or hypersensitivities to egg or soybean. Image Credit: © natali_mis - stock.adobe.com

Due to supply chain constraints, propofol is in chronic shortage and is currently on the American Society of Health System Pharmacists (ASHP) drug shortage list. As of June 3, 2024, ASHP indicates that shortages of propofol emulsion injections are due to increased demand and manufacturing delays, as well as the discontinuation of Teva's propofol in January 2023. The approval of Amneal’s complex emulsion injectable aims to overcome this obstacle to improve patient care and increase supply of crucial anesthetic treatments.^1,2

Propofol is an intraveneous surgical anesthetic used for procedural sedation, during monitored anesthesia care, or as an induction agent for general anesthesia. The mechanism of action has been largely misunderstood by the medical community, and prior studies have had conflicting results. However, in July of 2024 findings published in Neuron reported that propofol induces unconsciousness by disrupting the brain’s normal balance between stability and excitability, causing brain activity to become increasingly unstable until it loses consciousness.^3-5

Propofol is prepared in a lipid emulsion, which contains soybean oil, glycerol, egg lecithin, and a small amount of the preservative EDTA. Because of this, it is contraindicated for patients with any allergies or hypersensitivities to egg or soybean. Common adverse effects include local pain at the injection site, hypotension, myoclonus, or discolored urine.^1,3

The FDA approval of propofol injectable emulsion is a crucial step towards addressing the historic chronic drug shortages experienced by propofol products. The company expects to fully launch propofol in the fourth quarter of 2024 and plans to manufacture the product in-house on a dedicated line to provide consistent supply.¹

“Amneal is keenly focused on delivering critical drugs that are in short supply,” Andy Boyer, executive vice president, chief commercial officer of Generics, said in a press release. “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.”¹

REFERENCES

1. Amneal receives u.s. fda approval for propofol injectable emulsion single dose vials. Amneal. August 20, 2024. Accessed August 20, 2024. https://www.businesswire.com/news/home/20240820807066/en/Amneal-Receives-U.S.-FDA-Approval-for-Propofol-Injectable-Emulsion-Single-Dose-Vials

2. Propofol emulsion injection. American Society of Health System Pharmacists. June 3, 2024. Accessed August 20, 2024. https://www.ashp.org/drug-shortages/current-shortages/drug-shortage-detail.aspx?id=651&loginreturnUrl=SSOCheckOnly

3. Propofol. National Library of Medicine. July 24, 2023. Accessed August 20, 2024. https://www.ncbi.nlm.nih.gov/books/NBK430884/#:~:text=Propofol%20is%20an%20intravenous%20anesthetic,some%20combination%20of%20the%20two

4. Study reveals how an anesthesia drug induces unconsciousness. MIT News. July 15, 2024. Accessed August 20, 2024. https://news.mit.edu/2024/study-reveals-how-anesthesia-drug-induces-unconsciousnes-0715

5. Eisen A, Kozachkov L, Bastos A, et al. Propofol anesthesia destabilizes neural dynamics across cortex. Neuron. July 15, 2024. doi:10.1016/j.neuron.2024.06.011