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The U.S. Food and Drug Administration has proposed withdrawing approval for ProAmatine, a drug to treat low blood pressure manufactured by Shire plc.
The U.K.-based specialty pharmaceutical company, whose Human Genetic Therapies division is headquarters in Cambridge and Lexington, has not conducted required post-approval studies of the drug, according to the FDA.
“We’ve worked continuously with the drug companies to obtain additional data showing the drug’s clinical benefits to patients,” said Norman Stockbridge, director of the division of cardiovascular and renal drugs in the FDA’s Center for Drug Evaluation and Research, in a statement. “Since the companies have not been able to provide evidence to confirm the drug’s benefit, the FDA is pursuing a withdrawal of the product.”
The drug was approved in 1996 under the FDA’s accelerated approval regulations for drugs that treat serious or life-threatening diseases, which requires that companies do post-market studies to verify there is a clinical benefit to patients through post-approval studies. The FDA said that this is the first time it has recommended that a drug approved under that program be taken off the market.
Shire has 15 days to request a hearing, and drug companies that produce a generic version of the drug, called midodrine hydrochloride, have 30 days to submit written comments on the withdrawal proposal. After that, the FDA will make a final decision on whether to take the drug off the market.
FDA officials noted that patients who currently take this medication should not stop taking it and should consult their health-care professional about other treatment options.
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