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Arcoxia Approval Status

FDA Approved: No
Brand name: Arcoxia
Generic name: etoricoxib
Company: Merck
Treatment for: Osteoarthritis

Arcoxia (etoricoxib) is a selective COX-2 inhibitor for treatment of osteoarthritis.

In April 2007, Merck & Co., Inc. announced the receipt of a Not Approvable Letter from the U.S. Food and Drug Administration (FDA), advising the company that the New Drug Application (NDA) for Arcoxia (etoricoxib) had not been approved.

Development Status and FDA Approval Process for Arcoxia

DateArticle
Apr 27, 2007Merck Receives Non Approvable Letter from FDA for Arcoxia(etoricoxib)
Apr 13, 2007Public Citizen: FDA Should Not Approve "Offspring of Vioxx" Painkiller
Apr 12, 2007FDA Advisory Committee Recommends Against Approval for Merck's NDAfor Arcoxia (etoricoxib)
Apr 11, 2007Statement by Merck & Co., Inc. Regarding FDA Arthritis Drugs Advisory Committee Meeting on Arcoxia (etoricoxib)
Apr  9, 2007Arthritis Foundation Chief Public Health Officer Testifies at FDA Hearing on Arcoxia
Nov 10, 2006Merck Responds to FDA-Issued Approvable Letters for Arcoxia (etoricoxib)
Jun 17, 2005Merck Provides Status Update on Ongoing Arcoxia Trials
Oct 29, 2004Merck Receives ’Approvable’ Letter for Arcoxia

Further information

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