The FDA has issued a Proposal to Withdraw Marketing Approval for ProAmatine (midodrine HCl, from Shire), used in the treatment of orthostatic hypotension, because required post-approval studies that verify the clinical benefit of the drug have not been done. ProAmatine, and its generics, was approved in 1996 under the FDA’s accelerated approval regulations for drugs that treat serious or life-threatening diseases. To date, neither the original manufacturer nor any generic manufacturer has demonstrated the drug’s clinical benefit.
Shire must respond to the FDA in writing within 15 days to request a hearing. If the company fails to do so, the opportunity for a hearing will be waived. Sponsors of generic versions of midodrine will have 30 days to submit written comments on the notice. If, after considering any relevant submissions, the FDA continues to believe that withdrawal of approval is warranted, approval of all midodrine products, including generic versions, will be withdrawn.
Patients who are currently taking ProAmatine should not stop taking their medication and should consult their healthcare provider about alternative treatment options.
For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm222640.htm.