ARTICLE | Company News

Shire to withdraw ProAmatine

August 18, 2010 12:10 AM UTC

Shire plc (LSE:SHP; NASDAQ:SHPGY) disclosed on Tuesday that it informed FDA last November of plans to withdraw ProAmatine midodrine for orthostatic hypotension, effective Sept. 30. Shire said it conducted postmarketing trials but the agency viewed them as inconclusive and required additional trials to maintain the product's approval. On Monday, FDA proposed to withdraw all midodrine products, including generic versions, because required post-approval studies verifying the clinical benefit of the drug have not been conducted. ...