In a widely expected decision, the FDA has issued a non-approvable letter for Merck's Arcoxia, an arthritis therapy that foundered on its safety data. An FDA expert committee resoundingly rejected the therapy in April and the agency told Merck that researchers would have to clearly demonstrate that Arcoxia's benefits outweighed its risks before it could gain approval in the U.S. The therapy is approved in 63 countries and ginned $265 million in sales last year, despite its membership in the same class of drugs as Vioxx.
- read the release on the rejection
- check out the report on the decision from CNN