August 17, 2010 (Silver Spring, Maryland) — The US Food and Drug Administration (FDA) is recommending the withdrawal of midodrine hydrochloride, currently used in the treatment of low blood pressure, because there are insufficient data to support its benefit.The necessary postmarketing studies needed to show the drug is effective have not been done, according to the agency. As a result, the FDA is proposing the drug be withdrawn from the market.Midodrine is manufactured by Shire Development Inc, as well as by generic drug companies, and was approved in 1996 under a regulation that allowed accelerated approval for drugs to treat serious or life-threatening diseases. A condition of the approval, however, was that Shire, the maker of the brand-name drug (ProAmatine), prove the clinical benefit in postapproval studies. So far, neither Shire nor the generic companies have shown that the drug has any clinical benefit, such as improving the ability to perform daily activities.
This is the first time the FDA has issued a proposal to withdraw a drug approved under the accelerated approval regulations.
This is the first time the FDA has issued a proposal to withdraw a drug approved under the accelerated approval regulations.
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