FDA Rips 'Troubling' Drug Promo In Repeat Warning Letter

Law360, New York (November 21, 2013, 4:16 PM EST) -- For the second time in three years, Kadmon Pharmaceuticals LLC has sent promotional literature with faulty information on safety and effectiveness, a "particularly troubling" repeat offense, the U.S. Food and Drug Administration said in a warning letter released Wednesday.

The FDA's admonishment concerns a "dear doctor" letter related to hepatitis C drug Ribasphere and accuses New York-based Kadmon of spotlighting the medicine's potential benefits while burying its many risks in fine print.

Kadmon's one-page letter focused almost entirely on positive attributes of Ribasphere, waiting until the...
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