FDA considers pulling ProAmantine
pharmafile | August 17, 2010 | News story | Sales and Marketing | FDA, Shire, post-marketing
Shire’s low blood pressure drug ProAmantine and generic copies could be withdrawn from the US market because no post-marketing studies have been submitted to the FDA.
The US regulator has announced that the drug will have to be withdrawn in what looks to be a clampdown on companies not fulfilling their obligations on post-marketing studies.
It says neither Shire nor any generic manufacturer has “demonstrated the drug’s clinical benefit, for example, by showing that use of the drug improved a patient’s ability to perform life activities.”
This is be the first time such a notice has been issued, and follows a Government Accounting Office (GAO) report released last October which criticised the FDA for not pursuing companies regarding post-marketing studies.
ProAmantine (midodrine hydrochloride) was approved in 1996 under the FDA’s accelerated approval because it was deemed a treatment for serious or life-threatening diseases. The drug is a treatment for the low blood pressure condition orthostatic hypotension.
Post-marketing studies of the drug, to prove its safety and efficacy are a condition of the approval, but these have not been filed with the regulator.
The US regulator says Shire must respond in writing within 15 days to request a hearing on the matter.
Generic makers of ProAmantine, including Apotex, Impax Laboratories, Mylan Pharma, Sandoz, and Upsher-Smith Laboratories, will have 30 days to submit written comments on the notice.
Norman Stockbridge, M.D., director of the division of cardiovascular and renal drugs in the FDA’s centre for drug evaluation and research, said: “We’ve worked continuously with the drug companies to obtain additional data showing the drug’s clinical benefits to patients.
“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.”
Ben Adams
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