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

Zelmac Cost Analysis Data Could Define Use - Committee Member

Executive Summary

Maintenance studies for Novartis' Zelmac should include a cost analysis component, FDA Gastrointestinal Drugs Advisory Committee member Michael Wolfe, MD, said June 26.

You may also be interested in...



Novartis Zelmac Dosing Instructions Among Remaining Issues In FDA Review

FDA will have to decide between a high dose or titrated regimen for Novartis' irritable bowel syndrome therapy Zelmac following a review by the Gastrointestinal Drugs Advisory Committee.

Glaxo Lotronex Formulary Kit Faulted For Implied Claims Beyond Studies

Glaxo Wellcome Lotronex marketing materials "contain unsubstantiated Health-Related Quality of Life, productivity and economic claims" not adequately supported by clinical studies, FDA charged in an April 28 letter from the agency's Division of Drug Marketing, Advertising & Communications.

Glaxo Lotronex Indication Would Cover One-Third Of IBS Patients

The recommended indication for Glaxo Wellcome's irritable bowel syndrome therapy Lotronex would cover about one-third of the U.S. IBS population.

Related Content

UsernamePublicRestriction

Register

PS036328

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

Cancel