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.”
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