FDA Will Allow Shire (SHPGY) to Keep ProAmatine on the Market

September 6, 2010, 5:12 PM

The Food and Drug Administration said that it will allow ProAmatine, also known as midodrine a Shire PLC (Nasdaq: SHPGY) low blood-pressure treatment to be kept on the market. The news comes after warning in August that the drug has yet to be proven effective.

Sandy Walsh, Food and Drug Administration representative said in a statement that that the federal agency will continue to allow consumers to access to ProAmatine saying “while the necessary data is collected and the legal issues get sorted out.

The FDA had proposed a withdrawal from the market for the drug and awaited Shire to schedule a meeting with the administration. ProAmatine was approved in 1996 based on great early results in treating low blood pressure. A follow-up study to show long-term benefits of the drug was never done and is mandatory.

Last year, Approximately 100,000 U.S. patients were prescribed ProAmatine or generic versions, according to the FDA.

Shire had originally decided to remove the drug from the market on Sept. 30. But the company no longer intends to do so.

Copies of the letter from the FDA  were sent to five generic companies who make the drug also, including Mylan Inc. and Novartis AG unit Sandoz Inc. The generic versions could be subject to market withdrawal, unless the manufacturers complete the study required.

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