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Shire Provides Update on ProAmatine® (midodrine HCl)
Date:9/22/2011

raise blood pressure in patients with SOH.  In 2000, Shire acquired ProAmatine and completed two clinical post-marketing trials as required and submitted the results to FDA in 2005.  FDA took the position that these trials were inconclusive and requested that additional trials be completed.  Shire disagrees with the FDA and believes that these trials, together with 15 years of clinical experience, have established the clinical efficacy of ProAmatine and provide the necessary data to support the full approval of ProAmatine.

Shire has no financial interest in midodrine; Shire no longer manufactures, distributes or markets ProAmatine.  Beginning in 2003 and continuing to today, midodrine has been manufactured and distributed by five (5) generic pharmaceutical companies.  As the NDA holder, Shire has continued to invest in the needed processes to ensure this medicine remains available for patients and their families who rely on it, and Shire has worked diligently with FDA to develop a path forward that would allow the NDA to maintain its marketing authorization thus allowing the generic versions of ProAmatine to remain available for patients.  

"We look forward to continuing our discussions with FDA related to either having the agency accept the current data submitted by Shire in 2005 that demonstrates the clinical efficacy of midodrine, or agreeing on new protocols for additional studies that further confirm the clinical efficacy of ProAmatine as a treatment for patients diagnosed with SOH," added Jonas.  Important Safety InformationWarning: Because ProAmatine® can cause marked elevation of supine blood pressure, it should be used in patients whose lives are considerably impaired despite standard clinical care. The indication for use of ProAmatine® in the treatment of symptomatic orthostatic hypotension is based primarily on a change in a surrogate marker of effectiveness, an increase in systolic blood pressure
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