TUESDAY, Aug. 17 (HealthDay News) -- In the absence of post-approval trials demonstrating the clinical benefits of midodrine hydrochloride (ProAmatine), the U.S. Food and Drug Administration has issued a proposal to withdraw approval of the drug.
Midodrine was approved in 1996 for the treatment of orthostatic hypotension under an accelerated process for the approval of drugs that treat serious or life-threatening conditions, but, to date, no manufacturer of the drug has followed through with the post-approval trials required for drugs that meet approval through the accelerated process.
The FDA is recommending that patients who use the drug do not stop taking it but consult with their health care providers about alternative options. The maker of the brand name drug, Shire Development Inc., has 15 days to respond to the agency's notice and request a hearing, and sponsors of generic versions of the drug have 30 days to comment.
"Since the companies have not been able to provide evidence to confirm the drug's benefit, the FDA is pursuing a withdrawal of the product," Norman Stockbridge, M.D., director of the Division of Cardiovascular and Renal Drugs in the FDA's Center for Drug Evaluation and Research, said in a statement.
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