/ Source: Reuters
Merck & Co. said Friday that U.S. regulators have decided not to approve the company’s experimental arthritis drug, the successor to its recalled Vioxx pill, until more safety and effectiveness data are obtained.
Instead, Merck said the Food and Drug Administration had given the experimental drug, Arcoxia, an “approvable” status, meaning it must still satisfy certain agency requirements before it can be sold in the United States.
Vioxx was recalled in late September after patients taking it for more than 18 months were shown to have twice the risk of heart attack and stroke as those taking dummy pills. That study was designed to determine whether Vioxx could prevent recurrence of colon polyps.