U.S. FDA Says Shionogi Of Japan Makes Misleading Claims For Cedax
This article was originally published in PharmAsia News
Executive Summary
U.S. FDA accused Japan's Shionogi of making misleading claims in its promotional material for the antibiotic Cedax (ceftibuten) for treating mild infections. The agency said Shionogi distributed promotional material for physicians without noting the drug's risks while claiming "excellent tolerability." According to FDA, Cedaxhas several side effects that were not mentioned in its promotional material. In a warning letter, the agency also said Shionogi claimed uses for the drug beyond the ranger of infections included in the agency's U.S. approval. (Click here for more