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SILVER SPRING, Md. The Food and Drug Administration may rescind its approval of a drug used to treat low blood pressure, saying that companies marketing it have failed to provide evidence of its clinical benefit.
The FDA said Monday that it might withdraw approval of the drug midodrine hydrochloride, used to treat orthostatic hypotension, a condition that renders patients unable to maintain blood pressure when upright, causing them to become dizzy or faint when standing. According to the agency, it would be the first such notice for a drug approved under its accelerated approval regulations.
The drug is widely available in generic form, having originally won approval under the FDA’s accelerated approval program in 1996 as the branded drug ProAmatine, made by Shire Development. One condition for the accelerated approval was that Shire had to demonstrate its clinical benefit in post-approval studies. But to date, the FDA said, neither Shire nor generic manufacturers has demonstrated that the drug has clinical benefits, such as improving a patient’s ability to perform various activities.
The FDA said it would provide an opportunity for a hearing to Shire and the generic companies. Apotex Corp., Impax Labs, Mylan, Sandoz and Upsher-Smith Labs make generic versions of the drug. The agency said Shire would have 15 days to request a hearing, while the generic companies would have 30 days to submit written comments on the notice.
Arepresentative of Shire could not be reached for comment.