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 News Archives   News Articles - Timeline   Results 1 - 10 of about 12 for celebrex + fda + spondylitis. (0.11 seconds) 
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2002  Search other dates

Merck Withdraws FDA Filing on Drug; Shares Drop 6%
New York Times - Mar 16, 2002
... of the spine called ankylosing spondylitis, which affects 350000 Americans. ... Sales of Celebrex in the United States last year were $2.4 billion, ...
Bad News: Merck Withdraws Arcoxia Application - Forbes
Merck Pulls Request for FDA's Approval of... - The Record - AccessMyLibrary.com (Free with registration)
Wall Street Journal... - New York Times - All 5 related - Related web pages

Merck Withdraws Arcoxia NDA
ICIS - Mar 25, 2002
Bextra, successor to Pharmacia/ Pfizer's $3 billion Celebrex (celecoxib), was FDA-approved in November. Key to the success of Arcoxia, analysts say, ...
Merck & Co shares drop as it withdraws NDA for... - Marketletter - Alacra Store ($9.94)
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Merck delays Arcoxia FDA approval. (Life Sciences)
$9.94 - Chemical Market Reporter - Alacra Store - Jun 17, 2002
... indication for ankylosing spondylitis, a chronic inflammatory disorder. ... In early June the FDA approved a revised label for Celebrex in CV safety. ...
Merck & Co will refile Arcoxia NDA in 2003 - Marketletter - Alacra Store ($9.94)
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COX-2 inhibitors face marketing challenges. (Newswire).(Brief Article)
Free with registration - Medical Marketing & Media - AccessMyLibrary.com - Jul 1, 2002
On the basis of a new study, with the acronym "CLASS," the FDA has concluded that Celebrex showed no clear advantage over ibuprofen or diclofenac, ...
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Vioxx cleared for RA in USA, while label changes reflect VIGOR data
$9.94 - Marketletter - Alacra Store - Apr 22, 2002
The FDA has yet to rule on a similar application by Pharmacia for Celebrex. Cardiovascular data also added to label However, the labeling for Vioxx will now ...
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Merck shares drop on application withdrawal - Mar. 15, 2002
CNNMoney.com - Mar 15, 2002
... application such as ankylosing spondylitis [inflammation of the spine]," said Adam Greene, ... "The FDA could have had some concerns with the drug. ...
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CHAPTER 1 INDUSTRY COMMENT
$320.00 - DATAMONITOR - Alacra Store - May 1, 2002
Food manufacturers and consumer groups are working with the FDA to increase ... lose market share under competition from both Celebrex and Bextra. ...
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CHAPTER 1 R&D UPDATE: ARTHRITIS
$920.00 - DATAMONITOR - Alacra Store - Jun 5, 2002
an expanded new drug application to the FDA. The new application will include new. efficacy data to support an indication for ankylosing spondylitis, ...
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Merck Struggles To Get It Right After Years Of Doing No Wrong Drug...
Free with registration - Investor's Business Daily - AccessMyLibrary.com - Mar 22, 2002
Only later do they apply to the FDA for the right to market the drug for other ... Ankylosing Spondylitis is an inflammatory disease that strikes the spine. ...
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Novartis' Prexige - prospects assessed in face of COX-2 market …
$9.94 - Marketletter - Alacra Store - Aug 19, 2002
"We await Phase III data on Prexige versus [Pfizer/Pharmacia's] Celebrex (celecoxib) ... In fact, the Lehman Bros analysts believe that the FDA will accept ...
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