sparlontm provigil modafinil cephalon inc nda 20 717 s 019 psychopharmacologic drugs advisory committee gaithersburg maryland march 23 2006 glenn b mannheim md division of psychiatry products outline background overview safety database common ae other psychiatric rashes potential public health impact closing comments current submission adhd children 6 11 yrs adolescents 12 17 dosage and administration maintenance dose 30 kg 340 mg qd 21 highest 7 9 times higher than adult 425 14 5 3 titration initial 85 increase in steps q 2 days availability 170 255 tablets study population with dsm iv full time school moderately to severely ill or greater cgi 4 wisc iii wiat ii a 80 minimal ld excluded co morbidities psychotic disorder suicide risk depression mood anxiety substance abuse etc stimulant non responders courses abnormal labs eg anc 1000 mm3 clinically significant illness wks baseline studies pivotal 309 & 311 identical week db flexible
