Moreover, Philadelphia-based Shire, said it told the FDA last November that it would pull the drug rather than conduct postmarketing studies that the FDA had requested.
A release posted on the company’s website, said the drug, which is sold under the brand name ProAmatine, would be withdrawn effective Sept. 30.
Yesterday, the FDA announced that it had never received evidence from postmarketing studies to confirm the drug’s efficacy and, without that proof, it planned to withdraw its approval.
When the agency announced its plans, it said that the withdrawal would be the first reversal of a marketing approval since the FDA began its fast-track program.
When a drug receives accelerated approval, the FDA requires postmarketing studies to confirm the drug’s benefit.
A Government Accounting Office report released last fall found that the FDA routinely failed to require such studies and even when the studies were completed, the FDA failed to act on the findings.