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

Negative Arcoxia Review May Reflect Increasingly High Hurdle For Me-Toos

Executive Summary

The Arthritis Drugs Advisory Committee's negative review of Merck's Arcoxia could be more indicative of the increasingly challenging regulatory environment for "me too" products than concerns over the Vioxx follow-on's safety profile

You may also be interested in...



Restricted Distribution Should Be Limited To Drugs With Unique Benefit – FDA

Risk management plans that include restricted distribution components should be limited to products that offer a unique benefit in a specific group of patients, according to FDA

Restricted Distribution Should Be Limited To Drugs With Unique Benefit – FDA

Risk management plans that include restricted distribution components should be limited to products that offer a unique benefit in a specific group of patients, according to FDA

Arcoxia Needs Further Study In 1,000s Of Patients, Or Discontinuation – Cmte

Merck's COX-2 inhibitor Arcoxia requires significant additional clinical safety and efficacy evaluation prior to approval, members of FDA's Arthritis Drugs Advisory Committee said in recommending against approval of the Vioxx follow-on for treatment of osteoarthritis

Related Content

UsernamePublicRestriction

Register

PS048283

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