NDAs approved by the FDA in 2015 (ordered by approval date)
Compounds in parentheses are not new molecular entities.
| Compound Name | DDI | HI/RI | PBPK | PGx | Therapeutic Class | Approval Date | Reference |
|---|---|---|---|---|---|---|---|
| Edoxaban | Y | Y | N | Y | Cardiovascular drugs | January 8 | FDA (2015w) |
| Palbociclib | Y | Ya | N | N | Cancer treatments | February 3 | FDA (2015n) |
| Lenvatinib | Y | Y | Y | Y | Cancer treatments | February 13 | FDA (2015q) |
| Panobinostat | Y | Y | Y | Y | Cancer treatments | February 23 | FDA (2015l) |
| Ceftazidime (and avibactam) | Y | Yb | N | N | Anti-infective agents | February 25 | FDA (2015d) |
| Isavuconazonium sulfatec | Y | Y | N | N | Anti-infective agents | March 6 | FDA (2015i) |
| Cholic acid | Yd | N | N | N | Metabolism disorder/endocrinology treatments | March 17 | FDA (2015f) |
| Ivabradine | Y | Y | N | N | Cardiovascular drugs | April 15 | FDA (2015g) |
| Deoxycholic acid | Yd | N | N | N | Metabolism disorder/endocrinology treatments | April 29 | FDA (2015p) |
| Eluxadoline | Y | Ye | N | Y | Gastrointestinal agents | May 27 | FDA (2015zc) |
| Cangrelor | Y | Yb | N | N | Cardiovascular drugs | June 22 | FDA (2015o) |
| Lumacaftor (and ivacaftor) | Y | Ye | N | N | Respiratory system agents | July 2 | FDA (2015u) |
| Sacubitrilc (and valsartan) | Y | Y | N | N | Cardiovascular drugs | July 7 | FDA (2015k) |
| Brexpiprazole | Y | Y | N | Y | Central nervous system agents | July 10 | FDA (2015v) |
| Sonidegib | Y | Ya | Y | N | Cancer treatments | July 24 | FDA (2015t) |
| Daclatasvir | Y | Y | N | N | Anti-infective agents | July 24 | FDA (2015j) |
| Flibanserin | Y | Y | N | Y | Central nervous system agents | August 18 | FDA (2015a) |
| Rolapitant | Y | Yf | N | N | Antiemetics | September 1 | FDA (2015za) |
| Uridine triacetatec | Y | N | N | N | Metabolism disorder/endocrinology treatments | September 4 | FDA (2015ze) |
| Cariprazine | Y | Yf | N | Ya | Central nervous system agents | September 17 | FDA (2015zd) |
| Trifluridine (and tipiracil) | Y | Ya | N | N | Cancer treatments | September 22 | FDA (2015r) |
| Insulin degludec | N | Y | N | N | Hormones | September 25 | FDA (2015y) |
| Aripiprazole lauroxilc | N | N | Yg | N | Central nervous system agents | October 5 | FDA (2015c) |
| Patiromer | Yd | N | N | N | Antidotes | October 21 | FDA (2015zb) |
| Trabectedin | Y | Yb | N | N | Cancer treatments | October 23 | FDA (2015zf) |
| Elvitegravir, cobicistat, emtricitabine (and tenofovir alafenamide fumarate sulfate)c | Y | Y | N | N | Anti-infective agents | November 5 | FDA (2015m) |
| Cobimetinib | Y | Yb | Y | N | Cancer treatments | November 10 | FDA (2015h) |
| Osimertinib | Yd | Ya | Y | N | Cancer treatments | November 13 | FDA (2015x) |
| Ixazomib citratec | Y | Yh | N | N | Cancer treatments | November 20 | FDA (2015s) |
| Alectinib | Y | Ya | Y | N | Cancer treatments | December 11 | FDA (2015b) |
| Sugammadex | Y | Yb | N | N | Antidotes | November 15 | FDA (2015e) |
| Selexipag | Y | Y | N | N | Cardiovascular drugs | November 21 | FDA (2015z) |
| Lesinurad | Y | Y | N | Y | Antigout and uricosuric agents | November 22 | FDA (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.