The Food and Drug Administration in March announced the first new animal drug granted to the Index of Legally Marketed Unapproved New Animal Drugs for Minor Species.
The drug Ovaprim—salmon gonadotropin-releasing hormone analogue plus domperidone—is indicated for use as a spawning aid in ornamental finfish broodstock.
An animal drug product intended for use in a minor species must be approved, conditionally approved, or indexed by the FDA to be legally marketed.
"We are very pleased about the listing of the first drug to the index," said Dr. Bernadette M. Dunham, FDA-CVM director. "What makes indexing so unique is that it allows the legal marketing of unapproved new animal drugs intended for minor species and it makes use of an integrated process of agency and outside-expert panel review."
The index is one incentive under the Minor Use and Minor Species Animal Health Act of 2004, which was strongly supported by the AVMA. The index is intended to allow companies to legally market veterinary drugs for minor species for which there are no human food safety concerns, without having to go through the long and expensive process of a new animal drug approval.
"In some cases, the potential market for a minor species drug is just too small to ever support the costs of the drug approval process," Dr. Dunham explained. "However, having drugs listed in the index will be especially helpful to veterinarians treating zoo animals, pocket pets, pet birds, or, as in this case, ornamental fish."
Inclusion in the index is largely based on an evaluation of the target animal safety and effectiveness of each specific product by a panel of qualified experts.
Minor species are all animals other than those of the major species and include sheep, goats, honey bees, zoo animals, ornamental fish, parrots, ferrets, and guinea pigs.
The index, however, is limited to non-food-producing minor species, with the exception of certain non-food early life stages of food animals, such as some fish eggs.