Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

UsernamePublicRestriction

Allergan's Freedom From Expression Suit Challenges Gov't REMS, Off-Label Powers

This article was originally published in The Pink Sheet Daily

Executive Summary

The firm wants to go beyond the REMS requirements and offer treatment guidance, not just risk information, about the use of Botox for spasticity, an unapproved condition.

You may also be interested in...



Botox Reimbursement Training Is Driving Factor In Allergan Settlement With DOJ

Allergen will pay $600 million for promoting the drug for headache and spasticity; government says company taught physicians how to bill for off-label uses.

Botox Reimbursement Training Is Driving Factor In Allergan Settlement With DOJ

Allergen will pay $600 million for promoting the drug for headache and spasticity; government says company taught physicians how to bill for off-label uses.

Waxman Staffer Ann Witt Rejoining FDA

The former DDAMC head will bring wide knowledge of promotion and follow-on biologic issues to policy discussions.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS068622

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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

Cancel