February 27, 2020
The U.S. Food and Drug Administration today announced the addition of Alfaxan Multidose IDX (alfaxalone), a sedative and anesthetic, to the Index of Legally Marketed Unapproved New Animal Drugs for Minor Species (the Index). The Index is a list of new animal drugs intended for use in minor species (those other than dogs, cats, horses, cattle, pigs, chickens and turkeys) that have had their safety and effectiveness affirmed through an alternative FDA review process.
The FDA indexed Alfaxan Multidose IDX for the following indications:
- For sedation and anesthesia in captive reptiles (e.g., leopard geckoes), excluding any food-producing species
- For sedation and anesthesia in captive amphibians (e.g., Australian toads), excluding any food-producing species
- For sedation and anesthesia in ornamental fish, including species used in research such as the zebra fish
- For sedation and anesthesia in captive species and pet birds in the orders Psittaciformes, Passeriformes, and Columbiformes (e.g., parakeets), excluding any food-producing species
- For sedation and anesthesia in non-human primates (e.g., lemurs)
- For sedation and anesthesia in captive rodents (e.g., chinchillas)
- For sedation and anesthesia in captive mustelids (e.g., ferrets)
- For sedation and anesthesia in captive marsupials (e.g., opossums)
- For induction of anesthesia and immobilization in captive minor species ungulates (e.g., alpaca), excluding any food-producing species
Most animal drugs reach the marketplace through the FDA’s New Animal Drug approval process – in fact, the agency first approved Alfaxan in 2012 for use in cats and dogs, finding it safe and effective as an anesthetic in those species. But, in many cases, minor species drug products are intended for uses that cannot reasonably go through the standard drug approval process. They are often intended for use in species too rare or varied to be used in traditional safety and effectiveness studies. Indexing is an alternative to the drug approval process for non-food producing minor species and non-food early life stages of food producing minor species, providing a faster and less expensive process to obtain legal marketing status for eligible products.
The FDA found that Alfaxan Multidose IDX was appropriate for adding to the Index after a qualified expert panel evaluated the safety and effectiveness of the product for sedation and anesthesia in multiple minor species and found that the benefits of using Alfaxan Multidose IDX for these uses outweighed its risks to the animals. The qualified expert panel drew its conclusions from a thorough review of literature on the use of alfaxalone for sedation and anesthesia in the minor species animals, as well as professional experience with the product. FDA scientists then reviewed and agreed with the conclusions of the qualified expert panel.
Alfaxan Multidose IDX is marketed by Jurox PTY LTD of New South Wales, Australia, as an injectable solution. Alfaxalone is classified by the Drug Enforcement Agency as a Schedule IV controlled substance.
- Alfaxan Multidose IDX Freedom of Information Summary
- The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species
- Minor Use/Minor Species
Issued by FDA Center for Veterinary Medicine.
For questions, Contact CVM.