Table 2

No confirmation of publications for confirmatory studies

Generic nameCompanyDrug indications where conditions fulfilledNumber of required confirmatory studies* Date drug received Notice of Compliance with conditions (year-month-day)Date drug fulfilled conditions (year-month-day)
AmprenavirGlaxoSmithKlineHIV/AIDS—two indicationsUnknown (all relevant material removed)2001-03-01
2001-11-21
2004-07-05
2004-07-05
AnastrozoleAstraZenecaBreast cancer1 (company responded but did not confirm publication)2004-06-202008-12-02
AztreonamGilead ScienceCystic fibrosis12009-07-172011-05-17
DabrafenibNovartisMultiple myeloma32015-03-062016-05-13
DeferasiroxNovartisTransfusion-related iron overload122016-02-142017-01-10
DeferasiroxNovartisThalassaemia12006-10-182016-12-02
DelavirdineViiv Healthcare CanadaHIV/AIDS—two indications61998-07-22
2000-04-25
2003-07-22
2003-07-22
ImatinibNovartisGastrointestinal stromal tumour; chronic myeloid leukaemia—two indications92001-09-20
2003-10-08
2007-04-24
2004-12-29
2010-06-17
2013-02-21
LetrozoleNovartisBreast cancer; Breast cancer32005-04-01
2006-10-06
2010-12-17
2010-12-17
NevirapineBoehinger IngelheimHIV/AIDSUnknown (all relevant material removed)1998-09-042004-09-13
NilotinibNovartisChronic myeloid leukaemia—three indications32008-09-09
2010-07-22
2011-06-23
2011-11-30
2011-08-18
2015-08-19
RaltegravirMerck FrosstHIV/AIDS22007-11-272009-03-04
RiluzoleAventisAmyotrophic lateral sclerosis1 (Company letter said results of study disclosed in Product Monograph but letter and Product Monograph did not give any information about whether or not study was published)2000-08-302007-11-29
TenofovirGilead ScienceHIV/AIDS32003-03-182005-07-20
TrametinibNovartisMelanoma32016-03-112016-05-13
  • *Based on information in Qualifying Notices (see text for definition of Qualifying Notice).