Pink Sheet 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


Otsuka Busulfex's Overall Survival Claim Does Not Survive CDER Advertising Scrutiny

This article was originally published in The Pink Sheet Daily

Executive Summary

Statistical analyses based on pivotal trial data and used to promote a drug must prove what they purport to prove, FDA's Office of Prescription Drug Promotion says in an NOV letter to Otsuka over a website for the leukemia drug Busulfex (busulfan).

You may also be interested in...

FDA Turns Off Otsuka’s Abilify Dimmer Switch Graphic

As lights go out on the franchise, FDA says pharmacology aid misleadingly suggests Abilify offers advantages over other treatments.

FDA Cites Gleevec For Promoting Unapproved Indications Three Weeks Before Expanding Label

Notice of violation letter to Novartis from FDA’s Office of Prescription Drug Promotion expresses concern about describing a patient with five-year survival data, a claim that was added to the label the following month.

DDMAC Slamming The Door On Open-Label Studies In Promotions

Nycomed gets a "notice of violation" letter for a flashcard that used open-label study data to make claims for its actinic keratoses treatment Solaraze (diclofenac).

Related Content





Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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