The FDA has proposed withdrawing approval of midodrine, a drug used to treat orthostatic hypotension, because required post-approval studies that verify the clinical benefit of the medication have not been done, the agency announced.
The drug, marketed as ProAmatine by Shire Development Inc., and as a generic by other companies, was approved in 1996 under the FDA’s accelerated approval regulations for drugs that treat serious or life-threatening diseases, according to an FDA press statement.
The agency issued a Proposal to Withdraw Marketing Approval and Notice of Opportunity for a Hearing to the companies that manufacture midodrine. “This is the first time the agency has issued such a notice for a drug approved under the FDA’s accelerated approval regulations,” the FDA stated.
About 100,000 patients in the United States filled prescriptions for brand or generic forms of midodrine in 2009, the agency noted.