First generic propofol injectable emulsion for dogs receives FDA approval

Photo: Andrii/Adobe Stock

Officials with the FDA have approved the first generic propofol injectable emulsion for dogs (PropofolVet Multidose; Parnell Technologies Pty, Ltd.). The new product is indicated for use as an injectable anesthetic in dogs, according to the FDA.¹

PropofolVet Multidose contains the same active ingredient as the FDA-approved brand name propofol injectable emulsion, PropoFlo 28 (Zoetis), which was first approved on February 4, 2011. Additionally, the FDA determined that Parnell’s newly approved generic equivalent contains no inactive ingredients that may significantly affect the bioavailability of the active ingredient.¹

Based in New South Wales, Australia, Parnell Technologies submitted data to the FDA in support of approval of its’ generic propofol injectable emulsion. According to the agency, no serious adverse effects were reported in an in-vivo blood-level study of 22 dogs that was conducted to show bioequivalence to the 10 mg/ml Zoetis PropoFlo 28.²

PropofolVet Multidose is dispensed by prescription. The product is supplied in a 10 mg/mL concentration in 20mL multidose vials.^1,2

According to the FDA, the drug is used for induction of anesthesia, maintenance of general anesthesia by intermittent bolus injections for short procedures, and induction of general anesthesia where maintenance is provided by inhalant anesthetics. It is not intended for food-producing animals and should be used in humans.²

References

1. FDA approves first generic propofol injectable emulsion for dogs. FDA. November 18, 2024. Accessed November f19, 2024. https://www.fda.gov/animal-veterinary/cvm-updates/fda-approves-first-generic-propofol-injectable-emulsion-dogs?utm_medium=email&utm_source=govdelivery
2. Freedom of Information Summary. FDA. November 18, 2024. Accessed November 19, 2024. https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/16265