Drug in regulatory limbo a headache for Shire, FDA

Consider the situation that Shire (ADR) faces with midodrine, a low blood-pressure medication used by about 100,000 patients annually. Shire no longer makes the drug, which has been on the market for 15 years under a temporary approval, as it never passed its final clinical trials. Shire wants the FDA's final approval, thus releasing the drug from regulatory limbo. Other considerations: FDA approval for Shire to conduct new trials, or an agency hearing that might kill the drug. Story

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