Drugmaker: Midodrine Withdrawal Plans Predated FDA's

Shelley Wood

August 19, 2010

August 19, 2010 (Philadelphia, Pennsylvania)— A drugmaker whose hypotension drug was the subject of an FDA drug withdrawal request earlier this week now says it had already intended to voluntarily withdraw the drug, long before the FDA went public with the proposal. In a statement [1], Shire says that the company notified the FDA and healthcare professionals in November 2009 with the news that the company was opting to withdraw midodrine hydrochloride [ProAmatine], used in the treatment of low blood pressure.

As reported by heartwire , the FDA recommended withdrawal of the drug August 16, noting that the necessary postmarketing studies required to show the drug to be effective have not been done, despite the product being approved in 1996.

But in a statement on its website, Shire states that it acquired the drug "as a part of the acquisition of Roberts Pharma in 1999, and Shire conducted and completed the postmarketing trials that the FDA required. The FDA, however, viewed these trials as inconclusive and required that additional trials be conducted for ProAmatine to maintain its marketing authorization."

Shire says its plan to withdraw midodrine was to go into effect September 30, 2010. The decision is not being driven by any safety concerns, the company added.

As previously reported by heartwire , makers of generic versions of the drug have 30 days (from the date of the FDA's first withdrawal proposal) to submit written comments. A final decision about whether or not to withdraw the drug would be made after any final submissions from drug makers and others are considered.

heartwire 's first story on the FDA's withdrawal proposal drew criticism from readers on the FDA's handling of the issue.