Avenacy Announces Launch of Propofol Injectable Emulsion, USP in the U.S. Market

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SCHAUMBURG, Ill.--(BUSINESS WIRE)--Apr 7, 2025--

Avenacy, a specialty pharmaceutical company focused on supplying critical injectable medications, today announced it has launched Propofol Injectable Emulsion, USP in the United States as a therapeutic generic equivalent for Diprivan® as approved by the U.S. Food and Drug Administration. Propofol Injectable Emulsion, USP is an intravenous general anesthetic and sedation drug indicated for:

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• Induction of General Anesthesia for Patients Greater than or Equal to 3 Years of Age
• Maintenance of General Anesthesia for Patients Greater than or Equal to 2 Months of Age
• Initiation and Maintenance of Monitored Anesthesia Care (MAC) Sedation in Adult Patients
• Sedation for Adult Patients in Combination with Regional Anesthesia
• Intensive Care Unit (ICU) Sedation of Intubated, Mechanically Ventilated Adult Patients

Avenacy's Propofol Injectable Emulsion, USP is available in 200 mg/20 mL, 500 mg/50 mL, and 1,000 mg/100 mL single-dose vials. In line with Avenacy’s mission to champion patient safety and streamline patient care, Propofol Injectable Emulsion, USP will feature the Company’s highly differentiated packaging and labeling to support accurate medication selection.

Avenacy will begin shipping Propofol Injectable Emulsion, USP to wholesale partners this week. The Company is supported by a global network of development and contract manufacturing partners that have undergone successful FDA inspections based on cGMP-standards.

Propofol Injectable Emulsion, USP had U.S. sales of approximately $315 million for the twelve months ending in December 2024. 1

Limitations of Use:

Propofol injectable emulsion is not recommended for induction of anesthesia below the age of 3 years or for maintenance of anesthesia below the age of 2 months because its safety and effectiveness have not been established in those populations [see Pediatric Use (8.4)].

Safety, effectiveness and dosing guidelines for propofol injectable emulsion have not been established for MAC sedation in the pediatric population; therefore, it is not recommended for this use [see Pediatric Use (8.4)].

Propofol injectable emulsion is not indicated for use in Pediatric ICU sedation since the safety of this regimen has not been established [see Pediatric Use (8.4)].

Please see link for Full Prescribing Information.

Diprivan® is a registered trademark of Fresenius Kabi USA.

1 Source: IQVIA

About Avenacy

Avenacy is a U.S.-based specialty pharmaceutical company focused on supplying critical injectable medications used to treat patients in various medically supervised settings, from acute care hospitals to outpatient clinics and physician offices. Through a rigorous and optimized selection process, the Company is building out a pipeline of high-quality FDA approved injectable products in order to ensure a resilient portfolio that can meet the needs of today’s dynamic drug supply chain. With an experienced team, commitment to quality and reliability, and product offerings intended to facilitate safe and efficient patient care, Avenacy strives to be a trusted partner for essential medications.

Avenacy was launched in 2023 and is headquartered in Schaumburg, IL. For more information, please visit http://www.avenacy.com/.

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KEYWORD: UNITED STATES NORTH AMERICA ILLINOIS

INDUSTRY KEYWORD: BIOTECHNOLOGY FDA HEALTH PHARMACEUTICAL MEDICAL SUPPLIES

SOURCE: Avenacy

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PUB: 04/07/2025 08:00 AM/DISC: 04/07/2025 08:01 AM

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