Merck sent data on heart risks as to the delayed arthritis drug Arcoxia. Arcoxis is/was to be a potential successor to the withdrawn painkiller Vioxx. The company said it seeks a government OK of Arcoxia in 30-milligram and 60-milligram dosages.
Merck supposedly expects the FDA's Arcoxia to take about six more months.
Arcoxia can be purchased in more than sixty countries but has been under review by the FDA since 2003.
Merck said its response to approvable letters issued on Arcoxia by the FDA includes results of the "Medal" clinical trial. The trial, begun in 2002, was specifically designed to evaluate Arcoxia's cardiovascular risks.