The US Food and Drug Administration (FDA) could withdraw approval of midodrine hydrochloride, a drug used to treat orthostatic hypotension.
The regulator is considering the move as required post-approval studies to determine the drug’s clinical benefit have not been conducted.
Go deeper with GlobalData
Midodrine hydrochloride, marketed as ProAmatine by Shire Development and as generic by other manufacturers, received approval in 1999, under the FDA’s accelerated approval regulations for drugs that treat serious or life-threatening diseases.
This approval requires the manufacturer to prove the clinical benefit of the drug to the patients through post-approval studies.
According to the FDA, neither the original manufacturer nor any generic manufacturer has done this to date.
The FDA is recommending patients who are currently taking this medication not to stop the drug immediately, but consult their healthcare professional for other treatment options.
How well do you really know your competitors?
Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.
Thank you!
Your download email will arrive shortly
Not ready to buy yet? Download a free sample
We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form
By GlobalDataOrthostatic hypotension is caused due to the inability to maintain blood pressure in upright position, and results in dizziness when the patient stands up.
