Shire Pharmaceuticals has announced plans to pull its hypotension drug ProAmatime from the market, following reports yesterday that US regulators are preparing to withdraw its approval.
The US Food and Drug Administration announced yesterday that it has issued a Proposal to Withdraw Marketing Approval of the hypotension drug ProAmatine (midodrine hydrochloride) and a Notice of Opportunity for a Hearing to Shire and generic manufacturers of the drug.
ProAmatine was approved in the US in 1996 under the accelerated approvals process but, according to the regulator, neither Shire nor any generic manufacturer has since demonstrated the drug’s clinical benefit, and so it has kicked off the process to remove its marketing approval.
However, Shire said in statement that while it did indeed conduct and complete the necessary post marketing trials for ProAmatine, the FDA considered the results to be inconclusive and so required additional studies to be carried out to maintain the marketing authorisation.
As spokesman for the company told PharmaTimes World News, sales of ProAmatine represent less than 0.1% of Shire’s total revenues, and so the company has elected to withdraw the product - effective September 30 - presumably not wanting to shell out more cash on more studies.
The company said it notified the FDA in November 2009 and healthcare professionals earlier this year of its decision, and also stressed there are no concerns regarding the safety of the drug.