Arcoxia
etoricoxib
Treatment for OsteoarthritisStatement by Merck & Co., Inc. Regarding FDA Arthritis Drugs Advisory Committee Meeting on Arcoxia (etoricoxib)
WHITEHOUSE STATION, N.J., April 10, 2007 - The following statement by Merck & Co., Inc. is in response to the public release of the background materials provided to members of the FDA Arthritis Drugs Advisory Committee in preparation for their meeting on April 12, 2007 to consider the New Drug Application for Arcoxia (etoricoxib).
Merck is seeking FDA approval for Arcoxia to treat the signs and symptoms of osteoarthritis. There is a need for additional treatment options for osteoarthritis.
Merck looks forward to presenting all of the data from our robust and comprehensive clinical development program for Arcoxia to the broad panel of experts selected by the FDA. We look forward to the opportunity to discuss Arcoxia with these experts and agency representatives.
Forward-Looking Statement
This statement contains "forward-looking statements" as that term
is defined in the Private Securities Litigation Reform Act of
1995. These statements are based on management's current
expectations and involve risks and uncertainties, which may cause
results to differ materially from those set forth in the
statements. The forward-looking statements may include
statements regarding product development, product potential or
financial performance. No forward-looking statement can be
guaranteed, and actual results may different materially from those
projected. Merck undertakes no obligation to publicly update
any forward-looking statement, whether as a result of new
information, future events, or otherwise. Forward-looking
statements in this statement should be evaluated together with the
many uncertainties that affect Merck's business, particularly those
mentioned in the cautionary statements in Item 1A of Merck's Form
10-K for the year ended Dec. 31, 2006, and in its periodic reports
on Form 10-Q and Form 8-K, which the Company incorporates by
reference.
Related Articles:
Merck Receives Non Approvable Letter from FDA for Arcoxia (etoricoxib) - April 27, 2007
Public Citizen: FDA Should Not Approve "Offspring of Vioxx" Painkiller - April 13, 2007
FDA Advisory Committee Recommends Against Approval for Merck's NDA for Arcoxia (etoricoxib) - April 12, 2007
Arthritis Foundation Chief Public Health Officer Testifies at FDA Hearing on Arcoxia - April 9, 2007
Merck Responds to FDA-Issued Approvable Letters for Arcoxia (etoricoxib) - November 10, 2006
Merck Provides Status Update on Ongoing Arcoxia Trials - June 17, 2005
Merck Receives ’Approvable’ Letter for Arcoxia - October 29, 2004
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