Groups Willing to Conduct Trials to Keep Shire’s ProAmatine on Market

An FDA announcement of its intent to withdraw approval of Shire’s low blood pressure treatment ProAmatine has spurred offers from groups to perform the postmarket trials necessary to keep it and its generic counterparts on the market. In addition, since the withdrawal announcement, the FDA has heard from professional organizations, doctors and patients voicing concern about losing access to ProAmatine (midodrine). As a result, the FDA plans to work with Shire, generic manufacturers and other organizations to discuss the data necessary to establish the efficacy of midodrine, the agency said.
Drug Industry Daily