The FDA granted Amneal Pharmaceuticals an Abbreviated New Drug Application (ANDA) approval for its propofol injectable emulsion USP, 200mg/20 mL (10 mg/mL), 500 mg/50 mL (10 mg/mL), and 1000 mg/100 mL (10 mg/mL), single-dose vials, the company announced in a release.1
Propofol, a medication commonly used in hospitals for anesthesia and sedation, has a history of chronic shortage due to supply chain restraints. As of June 3, 2024, the American Society of Health System Pharmacists has listed propofol on the short supply list, citing increased demand, manufacturing delays, and the discontinuation of Teva’s—formerly a major supplier—propofol product in January 2023.2
With FDA approval in tow, Amneal’s product could help mitigate current supply restraints and ensure that hospitals have access to the medication they need.
Key Takeaways
- The FDA granted Amneal Pharmaceuticals an ANDA approval for its propofol injectable emulsion single-dose vials.
- By providing a new source of propofol, Amneal can help ensure that hospitals have access to the drug they need for anesthesia and sedation, as well as alleviate the medication's history of chronic supply issues.
- Propofol is a preferred sedative agent for critically ill patients, offering benefits like shorter periods of mechanical ventilation compared to benzodiazepines. Amneal's product can help improve patient outcomes and reduce the reliance on outdated sedation practices.
“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 Pharmaceuticals, in the release.1 “This single dose formulation of propofol is an essential medicine utilized every day by hospitals for surgical use.”
READ MORE: Pharmacist Strategies for Mitigating Patient Harm, Inequities During Drug Shortages
Historically, benzodiazepines have been used to sedate critically ill patients.2 However, research has shown that lighter sedation with a reduced reliance on benzodiazepines can lead to shorter periods of mechanical ventilation. Propofol has since emerged as the preferred sedative agent, particularly for prolonged intubation and deep sedation.
But while propofol is generally favored, supply shortages have led providers to resort to outdated sedation practices, such as those involving benzodiazepines.2
The FDA approval of Amneal Pharmaceuticals' propofol injectable emulsion single-dose vials aims to address this challenge. The company anticipates full product launch in the fourth quarter of 2024 and plans to manufacture the product in-house on a dedicated line to provide consistent supply.1
“We are proud to provide our hospital customers with this hard-to-make product and help patients in need,” said Boyer.1 “With our large global manufacturing footprint, Amneal aims to be the provider of choice for complex products like propofol.”
Propofol is contraindicated in people who have known hypersensitivity to propofol, egg, or soybean. Common adverse effects include local pain at the injection site, confusion, headache, or dizziness.3
READ MORE: FDA Updates Resource Center
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References
3. Propofol (intravenous route). Fact sheet. Mayo Clinic. Accessed August 21, 2024. https://www.mayoclinic.org/drugs-supplements/propofol-intravenous-route/side-effects/drg-20488192?p=1
