Notwithstanding the warning signs, in 1943, Lafayette Pharmacal submitted an application to the FDA to market Pantopaque (NDA 5-319): note that Kodak held the Trademark, and jointly held the patent with Plati and Strain of Rochester University. (Company name NORAD).
The reviewer for the FDA, Van Winkle, expressed several serious concerns with respect to toxicity of the compound and the misleading labelling.
He remarked that the animal studies were insubstantial evidence of safety as almost anything
"was allowable except death"!
