Table 4

Timing of public availability of trial results for new drugs approved by the FDA in 2014

Trials in patients (excluding healthy volunteer trials) in NDAAll Clinical Trials in NDA
DrugAt FDA approval3 months postapproval6 months postapprovalAt FDA approval3 months post-approval6 months post-approval
% Publicly available trials% Participant data available% Publicly available trials% Participant data available% Publicly available trials% Participant data available% Publicly available trials% Participant data available% Publicly available trials% Participant data available% Publicly available trials% Participant data available
Zydelig606560656065194819481948
Harvoni456452666173256028613368
Lynparza504658696773504658696773
Dalvance637663766376507150715071
Invokamet828795899589458365877388
Esbriet709270927092477947794779
Xigduo XR658570937093528456925692
Farxiga746685958595716678947894
Xtoro679767976797509550955095
Otezla737193989398436660926092
Sivextro718871888699577967817190
Zontivity71998610086100639874997499
Belsomra333310010010010082724812481
Cerdelga3312100100100100252438563856
Jublia80988098100100679367937895
Movantik5057100100100100204845844584
Viekira Pak60838788100100156122652975
Zerbaxa175100100100100271193999399
Zykadia100100100100100100208120812081
Quartile 1505767886789204828693373
Quartile 37392100100100100528367937394
Median657685958698456650815084
  • FDA, Food and Drug Administration; NDA, new drug application.