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

Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced that it has received Abbreviated New Drug Application (“ANDA”) approval from the U.S. Food and Drug Administration (FDA) for 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.

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®, U.S. annual sales for propofol for the 12 months ended June 2024 were approximately $314 million.

About Amneal

Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in Bridgewater, NJ, is a global pharmaceuticals company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of over 280 generic and specialty pharmaceuticals, primarily within the United States. In its Generics segment, the Company is expanding across a broad range of complex product categories and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceuticals focused primarily on central nervous system and endocrine disorders, with a pipeline focused on unmet needs. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. For more information, please visit www.amneal.com.

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