ProAmatine Recall: FDA Proposes to Withdraw Drug Approval

The FDA is proposing to remove drug approval for the low blood pressure drug ProAmantine and its generics, which would result in a ProAmantine recall from the market. 

The FDA announced its intention to withdraw approval for ProAmantine on Monday after the manufacturer, Shire Development Inc. failed to show that the drug provided clinical benefits to its users. Before it takes the regulatory action, the FDA had to issue a Proposal to Withdraw Marketing Approval and Notice of Opportunity for a Hearing to Shire and the companies that make the generics.

ProAmantine (midodrine hydrochloride) was approved by FDA in 1996 for the treatment of the low blood pressure condition called orthostatic hypotension. It was approved under an accelerated process reserved for drugs that are needed to save lives. Under the terms of the approval, the manufacturers had to conduct post-market studies to show that the drug provided a clinical benefit to patients. At the time of its approval, all it needed to show FDA was a surrogate endpoint believed to be a predictor of actual clinical benefits, which in this case was increased blood pressure.

After 14 years, neither Shire nor the manufacturers of generic midodrine hydrochloride have provided proof that the drug actually helps individuals live longer or more comfortably, the FDA claims. The generic manufacturers include Apotex Corp., Impax Laboratories Inc., Mylan Pharmaceuticals, Sandoz Inc., and Upsher-Smith Laboratories.

In its press release announcing the proposed approval recall of ProAmatine, FDA officials state that this is the first time the agency has been forced to take this kind of action against a drug that has undergone the accelerated approval process.

“We’ve worked continuously with the drug companies to obtain additional data showing the drug’s clinical benefits to patients,” said FDA Cardiovascular and Renal Drugs Director Dr. Norman Stockbridge. “Since the companies have not been able to provide evidence to confirm the drug’s benefit, the FDA is pursuing withdrawal of the product.”

Shire has 15 days to respond to the FDA in writing to request a hearing or else the opportunity for a hearing will be waived. Generic manufacturers have 30 days to submit comments.