FDA already notified on ProAmatine withdrawal, says Shire

Shire says post-marketing data was submitted, but rejected by the FDA

Shire is to withdraw its product ProAmatine following a demand from the FDA early this week regarding post-marketing data on the drug.

On Monday the FDA announced that it would demand the withdrawal of all versions of the low blood pressure drug, because neither Shire nor any generic companies had provided post-marketing studies to prove its efficacy.

This is the first time such a notice has been issued, and looks to be the beginning of a crackdown on post-marketing obligations not being met by pharma companies.

Shire has now responded, and has quietly set the record straight on a few issues which the FDA’s statement did not mention.

The company says it has already supplied the FDA with post-marketing data, but that the regulator dismissed these as ‘inconclusive’ and demanded further trials.

Shire has, however, opted instead to simply withdraw the drug from the market, and says it informed the FDA and healthcare professionals about this decision as long ago as November last year.

The product will be removed from the market on 30 September, and Shire concluded by emphasising that the withdrawal is not related to any safety concerns about the drug.

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, and Shire acquired it as part of its takeover of Roberts Pharma in 1999.