ARTICLE | Clinical News

ProAmatine midodrine hydrocholride regulatory update

August 23, 2010 7:00 AM UTC

Shire disclosed last week that it had informed FDA last November of plans to withdraw orthostatic hypotension drug ProAmatine midodrine on 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. Earlier in the week, 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.

FDA granted Shire accelerated approval in 1996 to market the selective adrenergic receptor alpha ( ADRA) agonist as ProAmatine. Apotex Inc. (Toronto, Ontario); Impax Laboratories Inc. (NASDAQ: ...