March 19, 2009
FDA Announces New Animal Drug to the Index
First Drug Product Added to the Index of Legally Marketed Unapproved New Animal Drugs for Minor Species (the Index)
The Food and Drug Administration announced today 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.
An animal drug product intended for use in a minor species must be approved, conditionally approved, or indexed by the FDA in order to be legally marketed.
The Index is one incentive under the Minor Use and Minor Species (MUMS) Animal Health Act of 2004. It’s 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. 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.
Minor species are all animals other than the major species (cattle, horses, swine, chickens, turkeys, dogs, and cats), for example, sheep, goats, honey bees, zoo animals, ornamental fish, parrots, ferrets, and guinea pigs. However, the Index 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.
The holder of the Index listing for Ovaprim is Western Chemical Inc. of Ferndale, Washington. For additional information on Ovaprim, please see http://www.fda.gov/cvm/MUMSIndexList.htm.
Questions about the Index may be directed to Dr. Joan Gotthardt, Center for Veterinary Medicine (HFV-50), 7500 Standish Place, Rockville, MD 20855, 240-276-9331, Joan.Gotthardt@fda.hhs.gov.
For additional information on animal drugs for minor uses and minor species, please see http://www.fda.gov/cvm/minortoc.htm.
Issued by:
FDA, Center for Veterinary Medicine,
Communications Staff, HFV-12
7519 Standish Place, Rockville, MD 20855
Telephone: (240) 276-9300 FAX: (240) 276-9115
Internet Web Site: http://www.fda.gov/cvm
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