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

Rx Safety Cmte.’s Holmboe Sees Communication As Key To Risk Management

Executive Summary

Yale University's Eric Holmboe, MD, will be taking his second look at risk-management proposals for GlaxoSmithKline's Lotronex during the inaugural meeting of FDA's Drug Safety & Risk Management Subcommittee

You may also be interested in...



GSK Lotronex To Be Reviewed By FDA Drug Safety Cmte. In April

FDA's Drug Safety & Risk Management Subcommittee will review the safety of GlaxoSmithKline's withdrawn irritable bowel syndrome agent Lotronex (alosetron) on April 23

Lilly Forteo Osteoporosis Indication Approval Recommended With Restrictions

Lilly's Forteo should be approved for treatment of osteoporosis in postmenopausal women but restricted either to high-risk patients or second-line use, FDA's Endocrinologic and Metabolic Drugs Advisory Committee recommended July 27.

Glaxo's Lotronex Risk-Management Program Emphasizes Appropriate Use

Glaxo Wellcome is proposing an "appropriate use" campaign as the focus of its risk-management plan for Lotronex, the company told FDA's Gastrointestinal Drugs Advisory Committee June 27.

Latest Headlines
See All
UsernamePublicRestriction

Register

PS039722

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