ARTICLE | Company News

Shire to appeal proposed ProAmatine withdrawal

September 8, 2010 12:42 AM UTC

Shire plc (LSE:SHP; NASDAQ:SHPGY) said it no longer intends to withdraw ProAmatine midodrine and now plans to appeal FDA's proposal to pull the orthostatic hypotension drug because required post-approval studies were not conducted. Shire had originally planned to withdraw ProAmatine at the end of the month but decided to appeal after reviewing data for the drug.

FDA spokesperson Sandy Walsh said FDA will "continue to allow access to the drug while the necessary data is collected and the legal issues get sorted out;" however, she said the agency has not discontinued its proposal to withdraw the drug. Walsh's comments came after FDA received comments from healthcare providers who believe the drug to be effective and patients who believe it works for them. Walsh said the agency is "hopeful that one or more of the midodrine manufacturers will agree to sponsor the necessary studies so that the drug can continue to be marketed." She added that the agency wants to implement an expanded access program should any official action be taken to remove the product's marketing approval. ...