FDA To Revoke Approval For Low Blood Pressure Drug

Published 08/17 2010 08:30AM

Updated 08/17 2010 08:38AM

A drug used to treat low blood pressure has run afoul of U.S. regulators.

The Food and Drug Administration has announced plans to withdraw marketing approval for the drug midodrine. The medication is sold by Shire Development under the brand name ProAmatine, as well as generically.

It won accelerated approval from the FDA in 1996, but the agency claims none of the manufacturers have provided evidence that the drug is beneficial to patients.

Shire has two weeks left to request a hearing on ProAmatine. Generic manufacturers have just under a month.

The FDA says it will revoke approval for the drug if it gets no response from the drugmakers.

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