US FDA seeks withdrawal of Shire's ProAmatine and generic versions due to lack of post-marketing studies of the BP drug

The US Food and Drug Administration yesterday proposed withdrawing approval of midodrine, a drug used to treat the low blood pressure condition orthostatic hypotension, because required post-approval studies that verify the clinical benefit of the drug have not been carried out.

The drug, marketed as ProAmatine by Ireland-headquartered Shire and as a generic by others, was approved in 1996 under the FDA's accelerated approval regulations for drugs that treat serious or life-threatening diseases. That approval required that the manufacturer verify clinical benefit to patients through post-marketing studies. To date, neither the original manufacturer nor any generic manufacturer has demonstrated the drug's clinical benefit, for example, by showing that use of the drug improved a patient's ability to perform life activities, the FDA pointed out.

ProAmatine cited in GOA report as failing to confirm clinical benefit