Shire's hypotension drug ProAmatine likely to stay on US market, as FDA back-tracks

Ireland-headquartered drugmaker Shire plc (LSE: SHP) says that the US Food and Drug Administration has posted an update on its web site related to ProAmatine (midodrine), a drug approved for the treatment of symptomatic orthostatic hypotension, which the company said it would withdraw from the US market after the agency called for additional clinical data that it claimed it has already submitted (The Pharma Letters August 19 and 17).

Notably, said Shire, the FDA clarified that its prior announcement related to midodrine "did not represent the actual withdrawal of the medication from the market." Rather, the FDA stated that it "represented a step in the regulatory process."

"Shire is very pleased that FDA has stated that 'continued patient access to midodrine is a key agency priority' and that the FDA has taken action allowing midodrine to remain accessible to patients and their families who rely on this medicine," said Jeffrey Jonas, senior vice president of R&D at Shire. "We look forward to continuing our ongoing discussions with FDA related to the efficacy of this medicine," he added.