Healthy Skepticism Library item: 7215

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Merck sees FDA action on Vioxx successor in 6 mos.
Reuters 2006 Nov 10
http://yahoo.reuters.com/news/articlehybrid.aspx?storyID=urn:newsml:reuters.com:20061110:MTFH76789_2006-11-10_13-49-17_WEN9624&type=comktNews&rpc=44

Abstract:

Merck & Co. Inc. said on Friday it responded to concerns from the U.S. Food and Drug Administration about its long-delayed Arcoxia arthritis drug, and expects the agency’s review to last about six months.

Arcoxia, which is in the same class as Merck’s withdrawn Vioxx painkiller, has been under review by the FDA since December 2003. According to FDA policy, Merck said, the latest review would be expected to take until the end of April.

Merck said it is initially seeking approval of Arcoxia only for the symptomatic treatment of osteoarthritis for both 30 milligram and 60 milligram strengths.

Arcoxia is currently available in 62 countries, Merck said.