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PHILADELPHIA Shire has decided to withdraw its blood pressure drug from the market, the drug maker said Tuesday.
The company said it would withdraw the drug ProAmatine (midodrine hydrochloride), used to treat the low blood pressure condition orthostatic hypotension, on Sept. 30. Shire has marketed the drug since 1999, when it gained rights to it as part of its acquisition of Roberts Pharma. Several companies also make generic versions of the drug.
Shire’s decision follows the Food and Drug Administration’s announcement Monday that it was considering rescinding approval of branded and generic versions of the drug after post-marketing studies showed that it did not improve patients’ conditions.
The drug was approved in 1996 under the FDA’s accelerated approval regulations for drugs that treat serious and life-threatening medical conditions, and according to the FDA, it was the first time the agency had issued a notice that it would withdraw approval for a drug approved under those regulations.