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A differentiation between the two leading COX-2 inhibitors, Celebrex and Vioxx, has been established after more than two years on the market, but the changes may lead to gastric distress for marketers: the labeling changes focus on limitations rather than attributes.
On the basis of a new study, with the acronym "CLASS," the FDA has concluded that Celebrex showed no clear advantage over ibuprofen or diclofenac, in gastric safety, thereby eliminating its chief marketing claim. New labeling for Celebrex, co-marketed by Pharmacia and Pfizer, states that differences in the incidence of complicated ulcers and safety advantage in upper GI events are not statistically…
Source: HighBeam Research, COX-2 inhibitors face marketing challenges. (Newswire).(Brief Article)