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FDA sends Novartis letter about Zaditor ads
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U.S. regulators have issued an untitled letter to Novartis Ophthalmics regarding its marketing of an eye drop for ocular allergies.
The Food and Drug Administration letter calls a direct-to-consumer TV ad for Zaditor (ketotifen fumarate ophthalmic solution, 0.025%) and portions of its Web site “misleading” because of “unsubstantiated superiority claims and other claims that overstate the efficacy of the drug.” Novartis has omitted “important risk information” associated with the drug, the letter also states.
In the letter, addressed to Novartis Ophthalmics and posted on the FDA Web site, the agency notes that Zaditor’s Web site contains claims suggesting the drug is superior to oral antihistamine “allergy pills” as well as being superior to other prescription eye drops.
“FDA is not aware of substantial evidence or substantial clinical experience demonstrating that Zaditor is superior to oral allergy medicines or other prescription eye drops for eye allergies,” the letter states.
One issue raised by the FDA is the company’s claim suggesting Zaditor may offer long-term relief, when the approved product labeling indicates the drug is for the temporary prevention of itching. Also, in the consumer ad, the company “fails to clearly communicate, and thereby minimizes, the risks associated with … Zaditor” the letter says. Of particular concern is a fast-paced voiceover detailing the adverse events while the graphic shows a photo of the drug with other wording superimposed over it.
A Novartis spokesperson told Ocular Surgery News “these types of notices are fairly routine as a way to communicate (the FDA’s) objections to advertising and promotional materials. Nevertheless, we take any communication from the FDA very seriously and have already taken steps to address their concerns.”