Amneal Receives U.S. FDA Approval for Propofol Injectable Emulsion Single Dose Vials
Propofol is an essential surgical anesthetic in hospitals that is in chronic shortage
Complex emulsion injectable expands Amneal’s injectables portfolio
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 (ASHP) drug shortages list. Propofol has a history of shortage due to supply chain constraints. Amneal will manufacture the product in-house on a dedicated line to provide consistent supply. The Company 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 - Generics. “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.”
Propofol is contraindicated in people who have known hypersensitivity to propofol, egg or soybean. For full prescribing information, see package insert located here.
According to IQVIA®,
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Source: Amneal Pharmaceuticals, Inc.