TABLE 1

NDAs approved by the FDA in 2015 (ordered by approval date)

Compounds in parentheses are not new molecular entities.

Compound NameDDIHI/RIPBPKPGxTherapeutic ClassApproval DateReference
EdoxabanYYNYCardiovascular drugsJanuary 8FDA (2015w)
PalbociclibYYaNNCancer treatmentsFebruary 3FDA (2015n)
LenvatinibYYYYCancer treatmentsFebruary 13FDA (2015q)
PanobinostatYYYYCancer treatmentsFebruary 23FDA (2015l)
Ceftazidime (and avibactam)YYbNNAnti-infective agentsFebruary 25FDA (2015d)
Isavuconazonium sulfatecYYNNAnti-infective agentsMarch 6FDA (2015i)
Cholic acidYdNNNMetabolism disorder/endocrinology treatmentsMarch 17FDA (2015f)
IvabradineYYNNCardiovascular drugsApril 15FDA (2015g)
Deoxycholic acidYdNNNMetabolism disorder/endocrinology treatmentsApril 29FDA (2015p)
EluxadolineYYeNYGastrointestinal agentsMay 27FDA (2015zc)
CangrelorYYbNNCardiovascular drugsJune 22FDA (2015o)
Lumacaftor (and ivacaftor)YYeNNRespiratory system agentsJuly 2FDA (2015u)
Sacubitrilc (and valsartan)YYNNCardiovascular drugsJuly 7FDA (2015k)
BrexpiprazoleYYNYCentral nervous system agentsJuly 10FDA (2015v)
SonidegibYYaYNCancer treatmentsJuly 24FDA (2015t)
DaclatasvirYYNNAnti-infective agentsJuly 24FDA (2015j)
FlibanserinYYNYCentral nervous system agentsAugust 18FDA (2015a)
RolapitantYYfNNAntiemeticsSeptember 1FDA (2015za)
Uridine triacetatecYNNNMetabolism disorder/endocrinology treatmentsSeptember 4FDA (2015ze)
CariprazineYYfNYaCentral nervous system agentsSeptember 17FDA (2015zd)
Trifluridine (and tipiracil)YYaNNCancer treatmentsSeptember 22FDA (2015r)
Insulin degludecNYNNHormonesSeptember 25FDA (2015y)
Aripiprazole lauroxilcNNYgNCentral nervous system agentsOctober 5FDA (2015c)
PatiromerYdNNNAntidotesOctober 21FDA (2015zb)
TrabectedinYYbNNCancer treatmentsOctober 23FDA (2015zf)
Elvitegravir, cobicistat, emtricitabine (and tenofovir alafenamide fumarate sulfate)cYYNNAnti-infective agentsNovember 5FDA (2015m)
CobimetinibYYbYNCancer treatmentsNovember 10FDA (2015h)
OsimertinibYdYaYNCancer treatmentsNovember 13FDA (2015x)
Ixazomib citratecYYhNNCancer treatmentsNovember 20FDA (2015s)
AlectinibYYaYNCancer treatmentsDecember 11FDA (2015b)
SugammadexYYbNNAntidotesNovember 15FDA (2015e)
SelexipagYYNNCardiovascular drugsNovember 21FDA (2015z)
LesinuradYYNYAntigout and uricosuric agentsNovember 22FDA (2015zg)
  • N, studies not included in the NDA reviews; Y, studies included in the NDA reviews.

  • a Only population PK data are available for both HI and RI, and therefore are not included in this analysis.

  • b Only population PK data are available for RI, and therefore are not included in this analysis.

  • c Prodrug.

  • d Only preclinical data are presented.

  • e Only population PK data are available for HI, and therefore are not included in this analysis.

  • f Only population PK data are available for RI, and are not included in this analysis; clinical data are available only for HI.

  • g PBPK modeling and simulations were used to support historical PK data under different clinical situations for DDIs, but were not used to recommend dosage.

  • h Population PK data are presented for mild HI and mild/moderate RI; others are from clinical data.