Table 3

Compliance with FDAAA legal disclosure requirements

			‘Trial completion date’ interpretation					‘FDA approval date’ interpretation
Drug	NDA sponsor	Indication	# Trials analysed	% Registered	% Reported	% FDAAA compliant	# Trials analysed	% Registered	% Reported	% FDAAA compliant
Jublia	Dow/Valeant	Onychomycosis	2	100	0	0	2	100	0	0
Dalvance	Durata/Allergan	Skin infection	2	50	0	0	2	50	100	50
Farxiga	AstraZeneca*	Type 2 diabetes	17	100	12	12	17	100	59	59
Harvoni	Gilead	Hepatitis C	27	100	59	59	27	100	70	70
Sivextro	Cubist/Merck*	Skin infection	4	100	75	75	4	100	75	75
Zydelig	Gilead	Leukaemia	4	100	75	75	4	100	75	75
Xigduo XR	Astrazeneca*	Type 2 diabetes	13	100	23	23	13	100	77	77
Otezla	Celgene	Psoriasis	11	100	91	91	11	100	91	91
Viekira Pak	Abbvie	Hepatitis C	13	100	77	77	13	100	92	92
Belsomra	MerckSharpDohme	Insomnia	4	100	0	0	4	100	100	100
Zerbaxa	Cubist/Merck	Urinary and abdominal infections	6	100	0	0	6	100	100	100
Zontivity	MerckSharpDohme	Thrombotic cardiovascular events	3	100	0	0	3	100	100	100
Movantik	AstraZeneca	Constipation	6	100	17	17	6	100	100	100
Lynparza	AstraZeneca	Ovarian cancer	7	100	71	71	7	100	100	100
Esbriet	Genentech/Roche*	Pulmonary fibrosis	4	100	75	75	4	100	100	100
Invokamet	Janssen/J&J*	Type 2 diabetes	15	100	87	87	15	100	100	100
Cerdelga	Genzyme/Sanofi	Gaucher disease	3	100	100	100	3	100	100	100
Xtoro	Alcon/Novartis*	Otitis externa	2	100	100	100	2	100	100	100
Zykadia	Novartis	Lung cancer	1	100	100	100	1	100	100	100
Quartile 1			3	100	0	0	3	100	75	75
Quartile 3			13	100	87	87	13	100	100	100
Median			4	100	71	71	4	100	100	100

Full FDA-approved indications are listed in the online supplementary appendix 6.
*Some trials for this drug were sponsored by a company other than the New Drug Application (NDA) sponsor, including the below.
Farxiga: AZ reports that this drug approved by the FDA on 1 January 2014 and acquired from BMS on 2 January 14. AZ states that ‘the transition of Farxiga studies to AstraZeneca is still in progress. Results were to be posted before the transition to AstraZeneca, which did not occur within the timeline for newly approved products’. AZ has now posted results for the seven FDAAA-applicable studies that did not meet FDAAA requirements. Six out of seven were published in the medical literature on or before 30 days post FDA approval; the other was published after the 30-day cut-off.
Sivextro: Bayer/Trius sponsored four trials, three out of four were FDAAA compliant under the ‘approval date’ interpretation.
Xigduo XR: BMS cosponsored 10 trials with AstraZeneca, 9/10 were FDAAA compliant under the ‘approval date’ interpretation.
Esbriet: Intermune sponsored two trials, both were FDAAA compliant under the ‘approval date’ interpretation.
Invokamet: Mitsubishi Tanabe sponsored two trials, one out of two was FDAAA compliant under the ‘approval date’ interpretation.
Xtoro: Alcon sponsored two trials, both were FDAAA compliant under the ‘approval date’ interpretation.
AZ, AstraZeneca; BMS, Bristol Myers Squib; FDA, Food and Drug Administration; FDAAA, Food and Drug Administration Amendments Act; NDA, New Drug Application