FDA Threatens To Pull Blood Pressure Drug

Law360, New York (August 16, 2010, 6:09 PM EDT) -- The U.S. Food and Drug Administration said Monday it was considering withdrawing its approval of the drug midodrine hydrochloride because Shire PLC and generic-drug manufacturers did not perform clinical benefits studies as required after the medicine reached the market.

The drug, sold as ProAmatine by U.K.-based Shire, is used to treat low blood pressure and has been approved since 1996, the FDA said.

Neither Shire nor the generics manufacturers who sell the drug have completed studies verifying the clinical benefit to patients, the agency said....
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