Arthritis Information Basic Information Arthritis Studies Ibuprofen Chondroiten Glucosamine Traditional Treatments	Vibrant Life Home Web Family Of Three Chelation Formulas MSM Other VL Products The Wednesday Letter Frequently Asked Questions Testimonials	Arthritis Information Center Shopping Cart	Separate Search Page or search below
Navigation Help	MSM	Ingredients Technical	Write To Karl Loren	Table Of Contents

Arthritis

Health

FDA Continues to Review Merck's Bid To Tout Study on Arthritis Drug's Label

A WSJ.COM News Roundup
 

WHITEHOUSE STATION, N.J. -- Merck & Co. Inc. said federal regulators are still considering allowing packaging for its Vioxx arthritis medicine to claim it is safer for the stomach than some other anti-inflammatories.

The Food and Drug Administration has given the drug maker notice that its application to change its package label will be approved if additional information or material is submitted or specific conditions are met, Merck said Tuesday.

The notice, in what is known as an "approvable letter," is an indication the agency's review is continuing and doesn't constitute an approval of the application.

In February a federal advisory panel concluded that Vioxx was safer on the stomach than older painkillers. The panel suggested that the FDA allow Merck to include data proving this benefit on the label of the Vioxx packaging. Such a change could help persuade some doctors to prescribe Vioxx instead of rival Celebrex, which is co-marketed by Pfizer Inc. and Pharmacia Corp.

But the panel also noted that neither Vioxx nor Celebrex protects against heart attacks like aspirin and that this fact should be noted on the labels of both drugs.

Merck's victory in February came in part because the drug maker asked less from the panel than Pharmacia. The Peapack, N.J., drug maker had asked the agency to consider softening or dropping altogether the ulcer warning label on its drug, a warning that is standard on all such painkillers. But Merck sought simply to add the results of its large Vioxx study to its drug's label.

The companies have been locked in one of the drug industry's great marketing battles since they launched their respective pills in 1999. Both drugs achieved more than $2 billion in sales last year.

URL for this Article:
http://interactive.wsj.com/archive/retrieve.cgi?id=SB986910123431366458.djm

Hyperlinks in this Article:
(1) http://interactive.wsj.com/archive/retrieve.cgi?id=SB981672401186513228.djm
(2) http://interactive.wsj.com/archive/retrieve.cgi?id=SB981572140500901124.djm
(3) http://interactive.wsj.com/archive/retrieve.cgi?id=SB981499084575451998.djm
 

SUBSCRIBE:  The Wednesday Letter is a free electronic monthly newsletter written and published by Karl Loren.  You can view more than 50 back issues of this publication by clicking here.  The Wednesday Letter subscription list is maintained on a secure server, no name is ever given or sold to anyone, and it is never used except for this Newsletter.  It is automatically published on the Tuesday night just before the first Wednesday of every month.  You can subscribe to this free monthly electronic letter by entering your eMail address and name below.  You will then automatically receive a request for confirmation, sent to whatever address you have entered.  If you do NOT receive this confirmation request, then you will not be subscribed.  There may have been an error with your address and you should resubmit.  The letter is never sent twice to the same address -- so you do not have to worry about a duplicate subscription.  When you receive this confirmation request you must reply to it, or your subscription will not become active.  No one can subscribe your name, and address, without you being notified, and if you get an unwanted notice of subscription you only need to DO NOTHING and the subscription will NOT be active.

REMOVAL:  You can remove yourself from the subscription list in several different ways.  Click here to read about this entire newsletter system.  Every edition of The Wednesday Letter is delivered to your address with YOUR name and address in view on the letter, with a link that allows you to remove THAT name from the subscription list.  If you try to send this removal message from an address different from the one you used to send in your original confirmation, then you will get a warning notice first, sent to the subscription address, asking you to confirm that you want to be removed from the list -- by replying to THAT request for confirmation, you will then be automatically removed.  Thus, no one else can unsubscribe you, from some other computer, without your knowledge.  But, if you send in the unsubscribe notice from the same machine used to receive the Letter, then the removal from the subscription list is automatic.

Personal Message:  When you send a personal message to Karl Loren, you will receive a personal reply as per his instructions.  Karl pledges that every personal message will get a personal answer. When you provide your mail address, we will send you free information including our free catalog and a cassette tape lecture by Karl Loren about heart disease, no charge, by mail, even if outside the US.  You can select particular information you would like to receive, along with the free cassette tape and catalog.

You can reach Vibrant Life in many ways, including by mail to Vibrant Life, 2808 N. Naomi St., Burbank, CA 91504.  Within the US and Canada, use the toll free number:  (800) 523-4521, the local number:  (818) 558-1799, the FAX:  (818) 558-7299, eMail to kimberly@oralchelation.com or any one of the hundreds of message forms throughout the 50 web sites.  Vibrant Life normally ships the same day we get an order.  There are message forms on each of the 100,000+ pages on this and other sites where you can communicate with Vibrant Life.  Check out our companion site, at:  http://www.oralchelation.net where Karl's 2000 page book is published.  Karl Loren is the author and webmaster for this BOOK, as well as for another web site about ORAL CHELATION.  His personal philosophical articles are at PHILOSOPHY. 

Copyright © May 20, 2008 6:24 AM by Karl Loren on behalf of Vibrant Life, ALL RIGHTS RESERVED.  Permission is granted for non-commercial downloading, copying, distribution or redistribution on two conditions:  One, that some form of copyright notice is included in every copy distributed or copied, showing the copyright belonging to Vibrant Life, Burbank, CA, at www.oralchelation.com . The second condition is that the material is not to be used for any purpose contrary to the purposes and objectives of this site.  This permission does not extend to materials on this site which are copyrighted by others.