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

UsernamePublicRestriction
UsernamePublicRestriction

Entereg’s REMS To Assess Off-Label Use In Quarterly Reports To FDA

Executive Summary

Adolor will monitor off-label use of Entereg (alvimopan) under the Risk Evaluation and Mitigation Strategy for the postoperative constipation therapy, but the firm is silent on how it will handle situations of non-compliance with the drug's required controlled distribution system

You may also be interested in...



Fluoroquinolone REMS Will Survey Patients, Doctors on Understanding of Risk

FDA's risk evaluation and mitigation strategy for fluoroquinolone antibiotics requires manufacturers to survey patients and prescribers to make sure they understand the risks of tendon injury associated with the products

Fluoroquinolone REMS Will Survey Patients, Doctors on Understanding of Risk

FDA's risk evaluation and mitigation strategy for fluoroquinolone antibiotics requires manufacturers to survey patients and prescribers to make sure they understand the risks of tendon injury associated with the products

TNF Blockers’ Link To Cancer In Children Is Under FDA Investigation

FDA expects an investigation into the link between tumor necrosis factor blockers and lymphoma and other cancers in children will be completed in about six months

Related Content

UsernamePublicRestriction

Register

ID007083

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