Shire announced that it has engaged in consistent dialogue with the FDA to secure either final FDA approval of ProAmatine (midodrine) based on the data submitted following two post-marketing clinical trials, or establish an agreed development plan for conducting additional clinical trials. ProAmatine was approved in 1996 under Subpart H (an accelerated approval process) for the treatment of symptomatic orthostatic hypotension (SOH), with a post-approval commitment to conduct two clinical trials to verify the clinical effect of midodrine.
The initial approval was based on ProAmatine’s demonstrated ability to significantly 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. The FDA took the position that these trials were inconclusive and requested that additional trials be completed. ProAmatine is no longer manufactured or marketed. Midodrine remains available to patients from various generic manufacturers today as discussions between FDA and Shire continue concerning the status of ProAmatine’s New Drug Application.
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