ARTICLE | Company News

FDA proposes to withdraw midodrine

August 16, 2010 11:59 PM UTC

FDA proposed to withdraw midodrine because required post-approval studies of the orthostatic hypotension drug were not conducted by the original manufacturer or the five subsequent generic manufacturers. Shire plc (LSE:SHP; NASDAQ:SHPGY) received accelerated approval in 1996 to market the selective adrenergic receptor alpha (ADRA) agonist as ProAmatine. Apotex Inc. (Toronto, Ontario); Impax Laboratories Inc. (NASDAQ:IPXL); Mylan Inc. (NASDAQ:MYL); Sandoz Inc., a unit of Novartis AG (NYSE:NVS; SIX:NOVN); and Upsher-Smith Laboratories Inc. (Maple Grove, Minn.), market generic versions of midodrine. FDA said this the first time the agency has issued a proposed withdrawal notice for a drug approved under accelerated approval. ...