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.
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About 100,000 patients in the United States filled prescriptions for brand or generic forms of midodrine in 2009, the agency noted.
