Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) has announced that the U.S. Food and Drug Administration (FDA) has approved its Abbreviated New Drug Application (ANDA) for Propofol Injectable Emulsion USP in single-dose vials. The approved dosages include 200 mg/20 mL (10 mg/mL), 500 mg/50 mL (10 mg/mL), and 1,000 mg/100 mL (10 mg/mL).
Propofol, an intravenous drug essential for anesthesia and sedation, is currently listed as a shortage by the American Society of Health-System Pharmacists (ASHP) due to ongoing supply chain issues. Amneal Pharmaceuticals will address this shortage by manufacturing Propofol Injectable Emulsion in-house on a dedicated production line to ensure a steady supply.
“Amneal is committed to providing critical medications that are in short supply,” said Andy Boyer, Executive Vice President and Chief Commercial Officer – Generics. “This single-dose propofol formulation is crucial for daily surgical use in hospitals. We are proud to offer this complex product and support patients in need. With our extensive global manufacturing capabilities, Amneal aims to be the preferred supplier for challenging products like propofol.”
Propofol is not suitable for individuals with known allergies to propofol, eggs, or soybeans. For complete prescribing information, refer to the package insert.
According to IQVIA®, U.S. annual sales for propofol were approximately $314 million for the year ending June 2024.
About Amneal
Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX), based in Bridgewater, NJ, is a global pharmaceutical company that develops, manufactures, and distributes over 280 generic and specialty medications, primarily in the U.S. The company’s Generics segment focuses on complex products such as injectables and biosimilars, while its Specialty segment includes branded pharmaceuticals for central nervous system and endocrine disorders. Amneal also distributes pharmaceuticals and other products through its AvKARE segment, serving the U.S. federal government, retail, and institutional markets.
