Jurox Animal Health has won U.S. approval of an alternative product for veterinarians left with partially filled vials of the Alfaxan injectable anesthetic drug.
The Australian company reported July 11 that the Food and Drug Administration’s Center for Veterinary Medicine authorized Alfaxan Multidose, whose preserved formulation permits its use up to 28 days after the vial is opened.
“The new Multidose formula allows us to serve the large population of veterinarians who do not routinely use an entire vial in a single day’s surgical procedures,” said Jim Van Proosdy, U.S. country manager for Jurox. “The product will be available in 10 mL and 20 mL vials beginning Aug. 1.”
The new formulation, approved for use in cats and dogs, required extensive research.
“Our challenge in developing Multidose was retaining the existing product attributes in a preserved formulation,” said Kirby Pasloske, DVM, DVSc, DACVCP, the company’s North American director of technical services and research.
“Our R&D team was able to create a preserved formulation that was identical to the current product. When we tested original Alfaxan head to head with Alfaxan Multidose, the results were pharmacodynamic and pharmacokinetic bioequivalence.”