Table 1: Drugs with completed Notice of Compliance with conditions and number of confirmatory studies per drug
Generic drug nameCompanyDate of NOC/c(d/mo/yr)Date NOC/c fulfilled(d/mo/yr)Time from NOC/c to fulfillment, dNo. of unique confirmatory studies listed in Qualifying NoticeNo. of confirmatory studies with publications
Based on company responseBased on database search*No publication identified for study
Company responded
AbacavirGlaxoSmithKline04/06/199910/09/200182933NA
AlteplaseHoffmann-La Roche16/02/199926/01/2005217122NA
Anastrozole†AstraZeneca30/06/200402/12/200816163111
BortezomibJanssen-Ortho27/01/200511/09/20079571‡1‡NA
24/04/200611/09/20075051‡1‡NA
CapecitabineHoffmann-La Roche07/12/200523/10/2008105111NA
DarunavirJanssen-Ortho28/07/200611/02/200992922NA
DasatinibBristol-Myers Squibb26/03/200719/11/200996922NA
ExemestanePfizer12/05/200606/06/200875633NA
GefitinibAstraZeneca17/12/200318/12/200921934NA
LenalidomideCelgene17/01/200806/06/2013196711NA
Levodopa/carbidopaAbbVie01/03/200712/03/2014256822NA
PregabalinPfizer09/11/200729/06/201096311NA
Recombinant factor VIIaNovo Nordisk12/02/199919/03/2006231911NA
Riluzole†Sanofi-Aventis30/08/200029/11/200726471NA1
SorafenibBayer28/06/200612/06/200910503NA
SunitinibPfizer17/08/200623/04/201013453‡3‡NA
01/05/200823/04/20107221‡1‡NA
ZanamivirGlaxoSmithKline02/11/199926/08/2003139311NA
Total no. of distinct confirmatory studies/publications34 studies29 publications (31 studies)1 publication (1 study)2 studies
Company did not respond
AztreonamMerck (Gilead)17/06/200917/05/20116691NA1
DelavirdineViiV Healthcare22/07/199822/07/20031826NA1‡
25/04/200022/07/20031183NA1‡
ImatinibNovartis20/09/200129/12/200411967NA61
08/10/200317/06/201024441NA1
24/05/200721/02/201321001NA1
LetrozoleNovartis01/04/200517/12/201020862NA2
06/10/200617/12/201015331NA1
NilotinibNovartis09/09/200830/11/201111771NA1
22/07/201018/08/20113921NA1
RaltegravirMerck27/11/200704/03/20094632NA
TenofovirMerck (Gilead)18/03/200320/07/20058552NA2
Total no. of distinct confirmatory studies/publications24 studiesNA18 publications  (19 studies)5 studies

Note: NOC/c = Notice of Compliance with conditions.

*No company response or publication not confirmed by company.

†Company responded but did not confirm all studies.

‡One study or publication in common.

§Two studies in 1 publication.

¶All studies or publications in common.