22 US FDA says'no 'to zilenton approval Abbott Laboratories' antiasthmatic agent zileuton has not been approved by the US FDA because of inadequate data submitted in the marketing application , reports Mar ketletter:' Zileuton ['Leutral'] was expected to become the l ust leukotrtene-receptor antagonist to enter the US market. adds Scrip? The FDA had concerns about the lack of information on zileuton relating to preclinical toxicity studies and human liver function test abnormalities. 1,2 Abbott intends to discuss these issues with the FDA durin g tbe next few weeks. Other leukotriene antagonists that are nearing the US market include Zeneca's zafirlukast ['Accolate'], Merck & Co .'s MK-476 [' Singulair'] and SmithKline Beecham's pranlukast. Pranlukast is licensed to SmithKline Beecham for Western markets from One of Japan where it is already available as 'Onon Cap' for the treatment of asthma. Zileuton was recommended for approval by the FDA's Pulmonary-Allergy Drugs Advisory Committee in April this year." -See /nphanna 984: 22, 29 Apr 1995; 8003/ 4405 1. Hold up for AbbolIas FDA saysno IOrileuton M¥l<etleuer. 21, 30 Oct I99S 2. FDA wants lOOn: dau oa zileulOD. S<rip 2l173: 21, 31 Oct 1995 0156-27Q;W!II1 012.ooo221$Ol .0f!' Adl . UmlUd 1095. AM rig ttt.

US FDA says ‘no’ to zileuton approval

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Page 1: US FDA says ‘no’ to zileuton approval

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

0156-27Q;W!II1 012.ooo221$Ol .0f!'Adl . '~Ion.l UmlUd 1095. AM rig ttt.~