Vet drugmakers get Warning Letters too
The FDA's marketing folks care about our pets. Regulatory Focus reports that the regulator has issued a Warning Letter to AB Science for marketing its canine tumor drug Kinavet for unapproved, off-label uses.
The Food and Drug Administration found fault with website copy that said the drug is “potentially well-suited for treating non-oncology diseases, such as canine atopic dermatitis or feline asthma,” and that off-label use studies supported this supposition.
RF says the FDA also highlighted that its case against AB Science is “particularly compelling” because Kinavet's approval “explicitly prohibits a company from allowing its drug to be used outside of its approved labeling.”
The manufacturer also failed to include risk information, such as the warning that people should not touch the drug because of its association with birth defects and other problems.