Table 1

Drug-indication publications confirmed by companies

Generic nameManufacturerIndication(s)Number of distinct studies required listed in the Qualify NoticeNumber of distinct publications confirmed by companyDate drug received Notice of Compliance with conditions (year-month-day)Date drug fulfilled conditions (year-month-day)
AbacavirGlaxoSmithKlineHIV/AIDS331999-04-062001-09-01
AlteplaseHoffman-LaRocheStroke221999-02-162005-01-26
AnastrozoleAstraZenecaBreast cancer312004-06-202008-12-02
BortezomibJanssenRelapsed multiple myeloma112005-01-272007-09-11
CapecitabineHoffman-LaRocheBowel cancer112005-12-072008-10-23
CrizotinibPfizerLung cancer222012-04-252015-11-18
DarunavirJanssenHIV/AIDS222006-07-282009-02-11
DasatinibBristol-Myers SquibbChronic myeloid leukaemia—two indications332007-03-26
2011-07-19
2009-11-19
2015-11-26
EculizumabAlexionParoxysmal nocturnal haemoglobinuria222013-03-012015-06-30
ExemestanePfizerBreast cancer332006-05-122008-08-06
GefitinibAstraZenecaLung cancer43 (two studies published in one article)2003-12-172009-12-18
LenalidomideCelgeneMyelodysplastic syndromes112008-01-072013-06-06
Levodopa/carbidopaAbbVieParkinson’s disease222007-03-012014-03-12
PregabalinPfizerCentral neuropathic pain112007-11-092010-06-29
Recombinant factor VIIaNovo NordiskClotting disorders111999-02-122005-06-19
SimeprevirJanssenHIV/AIDS222015-01-302016-11-29
SorafenibBayerKidney cancer32 (two studies published in one article)2006-07-282009-06-12
SunitinibPfizerRenal cancer—two indications332006-08-17
2008-05-01
2010-04-23
2010-04-23
ZanamivirGlaxoSmithKlineInfluenza111999-08-262003-08-26