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Arcoxia (Etoricoxib) - COX-2 Selective Inhibitor - Drug Information

Drug information on the COX-2 selective inhibitor Arcoxia, generic name etoricoxib. Arcoxia is an investigational arthritis drug in development by Merck. On 04/27/2007, a non-approvable letter was issued for a FDA drug application filed for treating osteoarthritis symptoms. Merck will continue to market Arcoxia outside the United States. Arcoxia is currently sold in 63 countries.
  1. A - Z: Arthritis Drugs
  2. A - Z: Drug Costs
  3. A - Z: NSAIDs
  4. COX-2 Selective Inhibitors
  5. Inflammation
  6. Joint Pain
  7. Pain Relief

04/27/2007: FDA Rejects Approval of Arcoxia
04/27/2007, According to Merck, the maker of Arcoxia, the FDA issued a non-approvable letter in response to a New Drug Application for treating osteoarthritis. To gain approval, the FDA indicated that Merck would need to provide additional data in support of the benefit-to-risk profile for Arcoxia.

04/12/2007: Arcoxia Rejected By FDA Arthritis Advisory Committee
04/12/2007, Arcoxia (etoricoxib) was not recommended for approval today by the FDA Arthritis Advisory Committee. Arcoxia is sold in 63 countries, but is not approved in the United States. The FDA is not required to follow the recommendations of the Arthritis Advisory Committee but usually does.

08/24/2006 Arcoxia History: Preliminary Analysis of MEDAL Data
08/24/2006, Long-awaited study analysis for Arcoxia (etoricoxib), a COX-2 inhibitor Merck & Co. hope will be the successor to Vioxx, has yielded both positive and negative results based on preliminary review. The MEDAL (Multinational Etoricoxib and Diclofenac Arthritis Long-Term) Program consisted of three clinical trials - EDGE, EDGE II, and MEDAL.

06/17/2005 Arcoxia History: Arcoxia Trials Will Continue
06/17/2005, Merck & Co. announced two phase III trials will continue. Results from the trials known as Medal and Edge II are expected to be submitted to the FDA in 2006.

10/29/2004 Arcoxia History: Arcoxia Approval Delayed By FDA
10/29/2004, Merck has received an "approvable" letter from the U.S. Food and Drug Administration for Arcoxia. The FDA is requiring additional safety and efficacy data for Arcoxia before it will issue approval.

01/09/2004 Arcoxia History: Etoricoxib Shows Comparable Efficacy
01/09/2004, Etoricoxib is as effective and well tolerated as is diclofenac at improving pain and function in patients with hip or knee osteoarthritis, according to a double-blind, active comparator-controlled, parallel-group study, from Doctor's Guide.

06/17/2002 Arcoxia History: Etoricoxib For Back Pain, RA, & Gout
06/17/2002, The investigational COX-2 inhibitor etoricoxib is showing promise with respect to providing relief in many painful conditions, including back pain, rheumatoid arthritis (RA), and acute gouty arthritis (AGA), from Doctor's Guide.

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