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Group: Moderators
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FDA Lists First Drug for Minor Species Under MUMS Act
Ovaprim, a drug to aid spawning in ornamental finfish broodstock, in March became the first animal drug granted a listing on the Index of Legally Marketed Unapproved New Animal Drugs for Minor Species.
Minor species are all animals other than the major species: cattle, horses, swine, chickens, turkeys, dogs and cats.
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, an incentive under the Minor Use and Minor Species Animal Health Act of 2004, 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 approval process for new animal drugs.
Before a drug is included in the Index, its safety and effectiveness is evaluated by a panel of experts.
The holder of the Index listing for Ovaprim is Western Chemical Inc. of Ferndale, Wash.
May 2009 PET AGE
Steven Pro, yeah that is my real name.
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