Avenacy, a specialty pharmaceutical company focused on supplying critical injectable medications, 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.
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.
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)].
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.