First Drug Approved Under Indexing

The Food and Drug Administration announced the first new animal drug granted to the Index of Legally Marketed Unapproved New Animal Drugs for Minor Species, i.e. the index. The drug, Ovaprim (salmon gonadotropin releasing hormone analog plus domperidone), is indicated for use as a spawning aid in ornamental finfish broodstock.

The index is one incentive under the Minor Use and Minor Species (MUMS) Animal Health Act of 2004. It is intended is 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.

Inclusion in the index is largely based on the evaluation of the target animal safety and effectiveness of each specific product by a panel of qualified experts.

For additional information on animal drugs for MUMS, please see www.fda.gov/cvm/minortoc.htm.