FDA warns Shionogi to end unsupported Cedax claims

ROCKVILLE, Md. The Food and Drug Administration released a warning letter to Shionogi and Co. Tuesday regarding its antibiotic Cedax.

The FDA said the company made inflated claims about Cedax (ceftibuten) and downplayed the health risks associated with it. Promotional materials sent to doctors claimed the drug had “excellent tolerability,” even though data did not support the claim.

The drug is approved for treating mild to moderate bacterial infections.