ArcoxiaTreatment for Osteoarthritis
Statement 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.
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.
Posted: April 2007
- 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