Scrip is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


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



Ask The Analyst

Please Note: Click here for more information on the Ask the Analyst service.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts