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FDA Approves First Generic Propofol Injectable Emulsion for Dogs

• The FDA has approved the first generic propofol injectable emulsion, PropofolVet Multidose, for use as an anesthetic in dogs. • PropofolVet Multidose, developed by Parnell Technologies, contains the same active ingredient as the brand-name PropoFlo 28 (Zoetis). • The FDA determined that the generic formulation contains no inactive ingredients that significantly affect the bioavailability of propofol. • The approval was supported by bioequivalence data from an in-vivo blood-level study in dogs, with no serious adverse effects reported.

The U.S. Food and Drug Administration (FDA) has given the green light to the first generic propofol injectable emulsion for dogs, named PropofolVet Multidose and manufactured by Parnell Technologies Pty, Ltd. This approval marks a significant development in veterinary medicine, offering a cost-effective alternative to the existing brand-name product, PropoFlo 28 (Zoetis). PropofolVet Multidose is indicated for use as an injectable anesthetic in dogs.
The FDA's decision is based on the determination that PropofolVet Multidose contains the same active ingredient as PropoFlo 28, which was initially approved on February 4, 2011. Furthermore, the agency has confirmed that the generic formulation does not include any inactive ingredients that could substantially impact the bioavailability of the active component, propofol.
Parnell Technologies, based in New South Wales, Australia, provided data to the FDA to support the approval of its generic propofol injectable emulsion. The submitted data included results from an in-vivo blood-level study involving 22 dogs, designed to demonstrate bioequivalence to Zoetis' PropoFlo 28. According to the FDA, the study reported no serious adverse effects.
PropofolVet Multidose will be available by prescription only and is supplied in a 10 mg/mL concentration in 20mL multidose vials. The FDA specifies that the drug is suitable for the induction of anesthesia, maintenance of general anesthesia via intermittent bolus injections for short procedures, and induction of general anesthesia when maintenance is provided by inhalant anesthetics. It is important to note that this product is not intended for use in food-producing animals or humans.
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Reference News

[1]
First generic propofol injectable emulsion for dogs receives FDA approval - DVM360
dvm360.com · Nov 19, 2024

FDA approves first generic propofol injectable emulsion for dogs, PropofolVet Multidose by Parnell Technologies, bioequi...

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