US FDA says ‘no’ to zileuton approval

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USFDAsays'no'to zilenton approvalAbbott Laboratorie s' antiasthm atic agent zileuton

has not been approved by the US FDA because ofinadequate data submitted in the marketing applica­tion , reports Marketletter:' Zileuton ['Leutral'] wasexpected to become the lust leukotrtene-receptorantagonist to enter the US market . adds Scrip?

The FDA had concerns about the lack of informa­tion on zileuton relating to preclinical toxicity studiesand human liver function test abnormalities.1,2 Abbottintends to discuss these issues with the FDA duringtbe next few weeks.

Other leukotriene antagonists that are nearing theUS market include Zeneca's zafirlukast ['Accolate ' ],Merck & Co.'s MK-476 [' Singulair ' ] and SmithKlineBeecham's pranlukast. Pranlukast is licensed toSmithKline Beecham for Western markets from Oneof Japan where it is already available as 'Onon Cap'for the treatment of asthma.

Zileuton was recommended for approval by theFDA's Pulmonary-Allergy Drugs Advisory Committeein April this year."-See /nphanna 984: 22, 29Apr1995; 8003/4405

1. Hold upfor AbbolIas FDA saysnoIOrileuton dos~ier. M¥l<etleuer. 21, 30

Oct I99 S 2. FDA wants lOOn: dau oa zileulOD. S<rip 2l173: 2 1, 3 1 Oct 1995

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