PRODUCT NEWS: FDA Approves Alfaxan Multidose
The use of Alfaxan has grown rapidly among US veterinarians due to its wide safety margin. And now, a new product registration has been approved by the FDA to increase the drug’s shelf life.
Alfaxan is an intravenous injectable anesthetic for use in cats and dogs that has been available and used throughout the world since 2001. The FDA approved the product for use in the United States in 2014.
Now, the FDA Center for Veterinary Medicine has approved all technical sections for a new product registration of the drug in the United States: Alfaxan Multidose.
“Alfaxan is already one of the most versatile induction agents registered for cats and dogs and for use in both induction and maintenance of anesthesia,” Jim Van Proosdy, the COO and US country manager for Jurox Incorporated, the drug’s manufacturer, said. “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.”
- Drug Combinations for Safer, More Balanced Anesthesia
- Pros, Cons of Multimodal Anesthesia
Alfaxan Multidose contains the same unique formulation as the original Alfaxan, but with an added preservative system to extend its product shelf life 28 days after the vial has been first opened. The preserved formulation reduces the risk of microbial contamination, providing repeatable and reliable anesthesia.
With Alfaxan Multidose, the Jurox research team was able to create a preserved formulation that, when tested against the original product, produced results that were pharmacodynamic and pharmacokinetic bioequivalence—meaning the 2 formulations were inherently identical.
“The reason Alfaxan has grown so rapidly here in the United States is because it gives veterinarians a wide safety margin and can be used with confidence,” Van Proosdy said.
Alfaxan Multidose now brings the benefits of Alfaxan to the broadest possible range of veterinary surgeons across the United States, he continued.
The newly approved product will be available for purchase in 10 mL and 20 mL vials beginning August 1.