PREVALENCE OF NON-CYTOCHROME P450-MEDIATED METABOLISM IN FDA APPROVED ORAL AND
INTRAVENOUS DRUGS: 2006 – 2015
Matthew A. Cerny
Drug Metabolism and Disposition
Supplemental Table 1. Complete list of FDA approved drugs 2006 – 2015
Drug Name Active Ingredients Approval
Date Drug Type
Route of
Administration Exclusion Criteria Reference
Savaysa edoxaban 1/8/2015 Small Molecule Oral N.A. 1-3
Cosentyx secukinumab 1/21/2015 Protein Subcutaneous Drug Type 4
Natpara parathyroid horomone 1/23/2015 Peptide IV Drug Type 5
Ibrance palbociclib 2/3/2015 Small Molecule Oral N.A. 6
Lenvima lenvatinib 2/13/2015 Small Molecule Oral N.A. 7-10
Farydak panobinostat 2/23/2015 Small Molecule Oral N.A. 11-14
Avycaz ceftazidime (1989)
2/25/2015 Small Molecule
Combination IV N.A.
15, 16
avibactam
Cresemba isavuconazonium sulfate 3/6/2015 Small Molecule Oral/IV Prodrug 17-19
Unituxin dinutuximab 3/10/2015 Protein IV Drug Type 20
Cholbam cholic acid 3/17/2015 Small Molecule Oral No ADME Study 21-23
Corlanor ivabradine 4/15/2015 Small Molecule Oral N.A. 24-26
Kybella deoxycholic acid 4/29/2015 Small Molecule Subcutaneous Route 27
Viberzi eluxadoline 5/27/2015 Small Molecule Oral Insufficient Data 28
Kengreal cangrelor 6/22/2015 Small Molecule IV N.A. 29, 30
Orkambi lumacaftor
7/2/2015 Small Molecule
Combination Oral N.A.
31, 32
ivacaftor (2012)
Entresto sacubitril
7/7/2015 Small Molecule
Combination Oral Prodrug
33, 34
valsartan (1996)
Rexulti brexpiprazole 7/10/2015 Small Molecule Oral N.A. 35
Praluent alirocumab 7/24/2015 Protein Subcutaneous Drug Type 36
Odomzo sonidegib 7/24/2015 Small Molecule Oral N.A. 37-39
Daklinza daclatasvir 7/24/2015 Small Molecule Oral N.A. 40, 41
Addyi flibanserin 8/18/2015 Small Molecule Oral N.A. 42
Repatha evolocumab 8/27/2015 Protein Subcutaneous Drug Type 43
Varubi rolapitant 9/2/2015 Small Molecule Oral N.A. 44
Xuriden uridine triacetate 9/4/2015 Small Molecule Oral Prodrug 45
Vraylar cariprazine 9/17/2015 Small Molecule Oral No ADME Study 46
Lonsurf trifluridine (1980)
9/22/2015 Small Molecule
Combination Oral No ADME Study
47
tipiracil
Tresiba insulin degludec 9/25/2015 Protein Subcutaneous Drug Type 48
Aristada aripiprazole lauroxil 10/6/2015 Small Molecule IM Route 49
Praxbind idarucizumab 10/16/2015 Protein IV Drug Type 50
Veltassa patiromer 10/21/2015 Polymer Oral Drug Type 51
Yondelis trabectedin 10/23/2015 Small Molecule IV Insufficient Data 52-56
Strensiq asfotase alfa 10/23/2015 Protein Subcutaneous Drug Type 57
Nucala mepolizumab 11/4/2015 Protein Subcutaneous Drug Type 58
Genvoya
elvitegravir (2014)
11/5/2015 Small Molecule
Combination Oral Prodrug
59-61
cobicistat (2014)
emtricitabine (2004)
tenofovir alafenamide
Cotellic cobimetinib 11/10/2015 Small Molecule Oral N.A. 62-64
Tagrisso osimertinib 11/13/2015 Small Molecule Oral Insufficient Data 65
Darzalex daratumumab 11/16/2015 Protein IV Drug Type 66
Ninlaro ixazomib 11/20/2015 Small Molecule Oral Prodrug 67
Portrazza necitumumab 11/24/2015 Protein IV Drug Type 68
Empliciti elotuzumab 11/30/2015 Protein IV Drug Type 69
Kanuma sebelipase alfa 12/8/2015 Protein IV Drug Type 70
Alecensa alectinib 12/11/2015 Small Molecule Oral N.A. 71
Bridion sugammadex 12/11/2015 Small Molecule IV N.A. 72
Uptravi selexipag 12/22/2015 Small Molecule Oral Prodrug 73-76
Zurampic lesinurad 12/22/2015 Small Molecule Oral N.A. 77
Farxiga dapagliflozin 1/8/2014 Small Molecule Oral N.A. 78-80
Hetlioz tasimelteon 1/31/2014 Small Molecule Oral N.A. 81, 82
Vimizim elosulfase alfa 2/14/2014 Protein IV Drug Type 83
Northera droxidopa 2/18/2014 Small Molecule Oral No ADME Study 84
Myalept metreleptin 2/24/2014 Protein Subcutaneous Drug Type 85
Neuraceq florbetaben F 18 3/19/2014 Small Molecule IV Imaging Agent 86
Impavido miltefosine 3/19/2014 Small Molecule Oral No ADME Study 87
Otezla apremilast 3/21/2014 Small Molecule Oral N.A. 88-90
Tanzeum albiglutide 4/15/2014 Protein Subcutaneous Drug Type 91
Cyramza ramucirumab 4/21/2014 Protein IV Drug Type 92
Sylvant siltuximab 4/23/2014 Protein IV Drug Type 93
Zykadia ceritinib 4/29/2014 Small Molecule Oral N.A. 94, 95
Zontivity vorapaxar 5/8/2014 Small Molecule Oral N.A. 96-98
Entyvio vedolizumab 5/20/2014 Protein IV Drug Type 99
Dalvance dalbavancin 5/23/2014 Small Molecule IV No ADME Study 100, 101
Jublia efinaconazole 6/6/2014 Small Molecule Topical Route 102
Sivextro tedizolid phosphate 6/20/2014 Small Molecule Oral/IV Prodrug 103-106
Beleodaq belinostat 7/3/2014 Small Molecule IV No ADME Study 107
Kerydin tavaborole 7/7/2014 Small Molecule Topical Route 108
Zydelig idelalisib 7/23/2014 Small Molecule Oral N.A. 109-111
Striverdi Respimat olodaterol 7/31/2014 Small Molecule Inhalation Route 112
Jardiance empagliflozin 8/1/2104 Small Molecule Oral N.A. 113-117
Orbactiv oritavancin 8/6/2014 Small Molecule IV No ADME Study. 118, 119
Belsomra suvorexant 8/13/2014 Small Molecule Oral N.A. 120
Plegridy peginterferon beta-1a 8/15/2014 Protein Subcutaneous Drug Type 121
Cerdelga eliglustat 8/19/2014 Small Molecule Oral N.A. 122, 123
Keytruda pembrolizumab 9/4/2014 Protein IV Drug Type 124
Movantik naloxegol 9/16/2014 Small Molecule Oral N.A. 125-127
Trulicity dulaglutide 9/18/2014 Protein Subcutaneous Drug Type 128
Harvoni ledipasvir
10/10/2014 Small Molecule
Combination Oral
N.A. 129, 130
sofosbuvir (2013)
Akynzeo netupitant
10/10/2014 Small Molecule
Combination Oral N.A.
131-133
palonosetron (2003)
Lumason sulfur hexafluoride lipid microsphere 10/10/2014 Inorganic IV Drug Type 134
Ofev nintedanib 10/15/2014 Small Molecule Oral N.A. 135-138
Esbriet pirfenidone 10/15/2014 Small Molecule Oral No ADME Study 139, 140
Blincyto blinatumomab 12/3/2014 Protein IV Drug Type 141
Xtoro finafloxacin 12/17/2014 Small Molecule Topical (Otic) Route 142
Lynparza olaparib 12/19/2014 Small Molecule Oral N.A. 143, 144
Viekira Pak
paritaprevir
12/19/2014 Small Molecule
Combination Oral N.A.
145, 146
ritonavir (1996)
dasabuvir
ombitasvir
Zerbaxa ceftolozane
12/19/2014 Small Molecule
Combination IV N.A.
147, 148
tazobactam (1993)
Rapivab peramivir 12/19/2014 Small Molecule IV No ADME Study 149
Opdivo nivolumab 12/22/2014 Protein IV Drug Type 150
Nesina alogliptin 1/25/2013 Small Molecule Oral N.A. 151, 152
Kynamro mipomersen sodium 1/29/2013 Antisense Drug Subcutaneous Drug Type 153
Pomalyst pomalidomide 2/8/2013 Small Molecule Oral N.A. 154-157
Kadcyla ado-trastuzumab emtansine 2/22/2013 Protein (ADC) IV Drug Type 158
Osphena ospemifene 2/26/2013 Small Molecule Oral Insufficient Data 159-162
Lymphoseek technetium Tc 99m tilmanocept 3/13/2013 Elemental
Subcutaneous
Intradermal
Subareolar
Peritumoral
Drug Type 163
Dotarem gadoterate meglumine 3/20/2013 Small Molecule IV Imaging Agent 164
Tecfidera dimethyl fumarate 3/27/2013 Small Molecule Oral N.A. 165-167
Invokana canagliflozin 3/29/2013 Small Molecule Oral N.A. 168-171
Breo Ellipta fluticasone furoate (2007)
5/10/2013 Small Molecule
Combination Inhalation Route
172
vilanterol
Xofigo radium Ra 223 dichloride 5/15/2013 Elemental IV Drug Type 173
Tafinlar dabrafenib 5/29/2013 Small Molecule Oral N.A. 174-177
Mekinist trametinib 5/29/2013 Small Molecule Oral N.A. 178-180
Gilotrif afatinib 7/12/2013 Small Molecule Oral N.A. 181-183
Tivicay dolutegravir 8/12/2013 Small Molecule Oral N.A. 184-187
Brintellix vortioxetine 9/30/2013 Small Molecule Oral N.A. 188-191
Duavee conjugated estrogens (1942)
10/3/2013 Small Molecule
Combination Oral N.A.
192-196
bazedoxifene
Adempas riociguat 10/8/2013 Small Molecule Oral N.A. 197, 198
Opsumit macitentan 10/18/2013 Small Molecule Oral N.A. 199-201
Vizamyl flutemetamol F 18 10/25/2013 Small Molecule IV Imaging Agent 202
Gazyva obinutuzumab 11/1/2013 Protein IV Drug Type 203
Aptiom eslicarbazepine acetate 11/8/2013 Small Molecule Oral Prodrug 204-207
Imbruvica ibrutinib 11/13/2013 Small Molecule Oral N.A. 208-210
Luzu luliconozole 11/14/2013 Small Molecule Topical Route 211
Olysio simeprevir 11/22/2013 Small Molecule Oral N.A. 212, 213
Sovaldi sofosbuvir 12/6/2013 Small Molecule Oral Prodrug 214-218
Anoro Ellipta umeclidinium
12/18/2013 Small Molecule
Combination Inhalation Route
219
vilanterol (5/10/2013)
Voraxaze glucarpidase 1/17/2012 Protein IV Drug Type 220
Picato ingenol mebutate 1/23/2012 Small Molecule Topical Route 221
Inlyta axitinib 1/27/2012 Small Molecule Oral N.A. 222-225
Erivedge vismodegib 1/30/2012 Small Molecule Oral N.A. 226-229
Kalydeco ivacaftor 1/31/2012 Small Molecule Oral N.A. 230, 231
Zioptan tafluprost 2/10/2012 Small Molecule Opthalmic Route 232
Surfaxin
Lucinactant
(sinapultide, 1,2-dipalmitoyl-sn-
glycero-3-phosphocholine, 1-
palmitoyl-2-oleoyl-sn-glycero-3-
phosphoglycerol, and palmitic acid)
3/6/2012
Protein Small
Molecule
Combination
Intratracheal Drug Type 233
Omontys peginesatide 3/27/2012 Protein IV
Subcutaneous Drug Type
234
Amyvid florbetapir F18 4/6/2012 Small Molecule IV Imaging Agent 235
Stendra avanafil 4/27/2012 Small Molecule Oral N.A. 236, 237
Elelyso taliglucerase alfa 5/1/2012 Protein IV Drug Type 238
Perjeta pertuzumab 6/8/2012 Protein IV Drug Type 239
Belviq lorcaserin hydrochloride 6/27/2012 Small Molecule Oral N.A. 240-243
Myrbetriq mirabegron 6/28/2012 Small Molecule Oral N.A. 244-246
Prepopik
sodium picosulfate
7/16/2012 Small Molecule
Combination Oral No ADME Study
247 magnesium oxide
citric acid
Kyprolis carfilzomib 7/20/2012 Small Molecule IV No ADME Study 248, 249
Tudorza Pressair aclidinium bromide 7/23/2012 Small Molecule Inhalation Route 250
Zaltrap ziv-aflibercept 8/3/2012 Protein IV Drug Type 251
Stribild
elvitegravir
8/27/2012 Small Molecule
Combination Oral N.A.
252-256
cobicistat
emtricitabine (2006)
tenofovir disoproxil fumarate (2001)
Neutroval tbo-filgrastim 8/29/2012 Protein Subcutaneous Drug Type 257
Linzess linaclotide 8/30/2012 Peptide Oral Drug Type 258, 259
Xtandi enzalutamide 8/31/2012 Small Molecule Oral N.A. 260-262
Bosulif bosutinib 9/4/2012 Small Molecule Oral N.A. 263, 264
Aubagio teriflunomide 9/12/2012 Small Molecule Oral N.A. 265-268
Choline C 11 choline C 11 9/12/2012 Small Molecule IV Imaging Agent 269
Stivarga regorafenib 9/27/2012 Small Molecule Oral N.A. 270-272
Jetrea ocriplasmin 10/17/2012 Protein Intravitreal Drug Type 273
Fycompa perampanel 10/22/2012 Small Molecule Oral Insufficient Data 274, 275
Synribo omacetaxine mepesuccinate 10/26/2012 Small Molecule Subcutaneous Route 276
Xeljanz tofacitinib 11/6/2012 Small Molecule Oral N.A. 277-279
Cometriq cabozantinib 11/29/2012 Small Molecule Oral N.A. 280-282
Iclusig ponatinib 12/14/2012 Small Molecule Oral N.A. 283, 284
Raxibacumab raxibacumab 12/14/2012 Protein IV Drug Type 285
Signifor pasireotide 12/14/2012 Peptide IV Drug Type 286
Gattex teduglutide 12/21/2012 Peptide IV Drug Type 287
Juxtapid lomitapide 12/21/2012 Small Molecule Oral N.A. 288, 289
Sirturo bedaquiline 12/28/2012 Small Molecule Oral No ADME Study 290, 291
Eliquis apixaban 12/28/2012 Small Molecule Oral N.A. 292-295
Fulyzaq crofelemer 12/31/2012 Botanical Drug Oral Drug Type 296
DaTSCAN ioflupane (123
I) 1/14/2011 Small Molecule IV Imaging Agent 297
Natroba Spinosad
(~17:3 spinosyn A:spinosyn D) 1/18/2011
Small Molecule
Mixture Topical Route
298
Viibryd vilazodone 1/21/2011 Small Molecule Oral N.A. 299
Edarbi azilsartan medoxomil 2/25/2011 Small Molecule Oral Prodrug 300-302
Daliresp roflumilast 2/28/2011 Small Molecule Oral N.A. 303-306
Benlysta belimumab 3/9/2011 Protein IV Drug Type 307
Gadavist gadobutrol 3/14/2011 Small Molecule IV Imaging Agent 308
Yervoy ipilimumab 3/25/2011 Protein IV Drug Type 309
Caprelsa vandetanib 4/6/2011 Small Molecule Oral Insufficient Data 310, 311
Horizant gabapentin enacarbil 4/6/2011 Small Molecule Oral Prodrug 312-314
Zytiga abiraterone acetate 4/28/2011 Small Molecule Oral Prodrug 315-317
Tradjenta linagliptin 5/2/2011 Small Molecule Oral N.A. 318-320
Victrelis boceprevir 5/13/2011 Small Molecule Oral N.A. 321-323
Edurant rilpivirine 5/20/2011 Small Molecule Oral N.A. 324-326
Incivek telaprevir 5/23/2011 Small Molecule Oral N.A. 327-330
Dificid fidaxomicin 5/27/2011 Small Molecule Oral No ADME Study 331, 332
Potiga ezogabine 6/10/2011 Small Molecule Oral N.A. 333-335
Nulojix belatacept 6/15/2011 Protein IV Drug Type 336
Arcapta Neohaler indacaterol maleate 7/1/2011 Small Molecule Inhalation Route 337
Xarelto rivaroxaban 7/1/2011 Small Molecule Oral N.A. 338-341
Brilinta ticagrelor 7/20/2011 Small Molecule Oral N.A. 342-345
Zelboraf vemurafenib 8/17/2011 Small Molecule Oral N.A. 346-348
Adcetris brentuximab vedotin 8/19/2011 Protein IV Drug Type 349
Firazyr icatibant acetate 8/25/2011 Small Molecule Subcutaneous Route 350
Xalkori crizotinib 8/26/2011 Small Molecule Oral N.A. 351, 352
Ferriprox deferiprone 10/14/2011 Small Molecule Oral No ADME Study 353-355
Onfi clobazam 10/21/2011 Small Molecule Oral N.A. 356-358
Jakafi ruxolitinib 11/16/2011 Small Molecule Oral N.A. 359-361
Erwinaze asparaginase erwinia chrysanthemi 11/18/2011 Protein IM Drug Type 362
Eylea aflibercept 11/18/2011 Protein IV Drug Type 363
Actemra tocilizumab 1/8/2010 Protein IV
Subcutaneous Drug Type
364
Ampyra dalfampridine 1/22/2010 Small Molecule Oral N.A. 365-367
Victoza liraglutide 1/25/2010 Peptide Subcutaneous Drug Type 368
Xiaflex clostridial collagenase 2/2/2010 Protein Intralesional Drug Type 369
VPRIV velaglucerase alfa 2/26/2010 Protein IV Drug Type 370
Carbaglu carglumic acid 3/18/2010 Small Molecule Oral N.A. 371, 372
Asclera polidocanol 3/30/2010 Small Molecule IV No ADME Study 373
Natazia estradiol valerate(1954)
5/6/2010 Small Molecule
Combination Oral N.A.
374
dienogest
Lumizyme alglucosidase alfa 5/24/2010 Protein IV Drug Type 375
Prolia denosumab 6/1/2010 Protein Subcutaneous Drug Type 376
Jevtana cabazitaxel 6/17/2010 Small Molecule IV N.A. 377-379
Lastacaft alcaftadine 7/28/2010 Small Molecule Topical Route 380
Xeomin incobotulinum toxin A 7/30/2010 Protein IM Drug Type 381
Ella ulipristal acetate 8/13/2010 Small Molecule Oral N.A. 382-384
Krystexxa pegloticase 9/14/2010 Protein IV Drug Type 385
Gilenya fingolimod 9/21/2010 Small Molecule Oral Prodrug 386-389
Pradax dabigatran etexilate mesylate 10/19/2010 Small Molecule Oral Prodrug 390-395
Latuda lurasidone 10/28/2010 Small Molecule Oral N.A. 396, 397
Teflaro ceftaroline fosamil 10/29/2010 Small Molecule IV Prodrug 398, 399
Egrifta tesamorelin 11/10/2010 Peptide Subcutaneous Drug Type 400
Halaven eribulin mesylate 11/15/2010 Small Molecule IV N.A. 401, 402
Savella milnacipran 1/14/2009 Small Molecule Oral N.A. 403, 404
Uloric febuxostat 2/13/2009 Small Molecule Oral N.A. 405-407
Afinitor everolimus 3/30/2009 Small Molecule Oral N.A. 408-411
Coartem artemether
4/7/2009 Small Molecule
Combination Oral No ADME Study
412
lumefantrine
Ulesfia benzyl alcohol 4/9/2009 Small Molecule Topical Route 413
Simponi golimumab 4/24/2009 Protein Subcutaneous Drug Type 414
Dysport abobotulinum toxin A 4/29/2009 Protein IM Drug Type 415
Fanapt iloperidone 5/6/2009 Small Molecule Oral N.A. 409, 410, 416
Samsca tolvaptan 5/19/2009 Small Molecule Oral N.A. 417-419
Besivance besifloxacin 5/28/2009 Small Molecule Topical Route 420
Ilaris canakinumab 6/17/2009 Protein Subcutaneous Drug Type 421
Multaq dronedarone 7/1/2009 Small Molecule Oral N.A. 422-424
Effient prasugrel 7/10/2009 Small Molecule Oral Prodrug 425-429
Onglyza saxagliptin 7/31/2009 Small Molecule Oral N.A. 430-434
Livalo pitavastatin 8/3/2009 Small Molecule Oral N.A. 431-433, 435
Saphris asenapine 8/13/2009 Small Molecule Oral N.A. 436-438
Sabril vigabatrin 8/21/2009 Small Molecule Oral N.A. 439, 440
Bepreve bepotastine besilate 9/8/2009 Small Molecule Opthalmic Route 441
Vibativ telavancin 9/11/2009 Small Molecule IV N.A. 442, 443
Folotyn pralatrexate 9/24/2009 Small Molecule IV No ADME Study 444
Stelara ustekinumab 9/25/2009 Protein Subcutaneous Drug Type 445
Votrient pazopanib 10/19/2009 Small Molecule Oral N.A. 446-448
Arzerra ofatumumab 10/26/2009 Protein IV Drug Type 449
Istodax romidepsin 11/5/2009 Small Molecule IV Prodrug 450
Qutenza capsaicin 11/16/2009 Small Molecule Topical Route 451
Kalbitor ecallantide 12/1/2009 Protein Subcutaneous Drug Type 452
Intelence etravirine 1/18/2008 Small Molecule Oral N.A. 453-455
Arcalyst rilonacept 2/27/2008 Protein Subcutaneous Drug Type 456
Pristiq desvenlafaxine succinate 2/29/2008 Small Molecule Oral Insufficient Data 457, 458
Treanda bendamustine 3/20/2008 Small Molecule IV Insufficient data 459
Lexiscan regadenoson 4/10/2008 Small Molecule IV Imaging Agent 460, 461
Cimzia certolizumab pegol 4/22/2008 Protein Subcutaneous Drug Type 462
Relistor methylnaltrexone bromide 4/24/2008 Small Molecule Subcutaneous Route 463
Entereg alvimopan 5/20/2008 Small Molecule Oral N.A. 464, 465
Durezol difluprednate 6/23/2008 Small Molecule Topical Route 466
Eovist gadoxetate disodium 7/3/2008 Small Molecule IV Imaging Agent 467
Cleviprex clevidipine butyrate 8/1/2008 Small Molecule IV Prodrug 468
Xenazine tetrabenazine 8/15/2008 Small Molecule Oral N.A. 469-471
Nplate romiplostim 8/22/2008 Protein Subcutaneous Drug Type 472
AdreView iobenguane sulfate I-123 9/19/2008 Small Molecule IV Imaging Agent 473
Rapaflo silodosin 10/8/2008 Small Molecule Oral N.A. 474-477
Vimpat lacosamide 10/28/2008 Small Molecule Oral/IV N.A. 478-482
Toviaz fesoterodine fumarate 10/31/2008 Small Molecule Oral Prodrug 483, 484
Banzel rufinamide 11/14/2008 Small Molecule Oral N.A. 485-487
Promacta eltrombopag olamine 11/20/2008 Small Molecule Oral N.A. 488-490
Nucynta tapentadol 11/20/2008 Small Molecule Oral N.A. 491, 492
Lusedra fospropofol disodium 12/12/2008 Small Molecule IV Prodrug 493
Mozobil plerixafor 12/15/2008 Small Molecule Subcutaneous Route 494
Ablavar gadofosveset trisodium 12/22/2008 Small Molecule IV Imaging Agent 495
Firmagon degarelix acetate 12/24/2008 Small Molecule Subcutaneous Route 496
Vyvance lisdexamfetamine dimesylate 2/23/2007 Small Molecule Oral Prodrug 497
Tekturna aliskiren 3/5/2007 Small Molecule Oral N.A. 498-500
Tykerb lapatinib 3/13/2007 Small Molecule Oral N.A. 501-505
Soliris eculizumab 3/16/2007 Protein IV Drug Type 506
Altabax retapamulin 4/12/2007 Small Molecule Topical Route 507
Neupro rotigotine 5/9/2007 Small Molecule Topical
Transdermal Route
508
Torisel temsirolimus 5/30/2007 Small Molecule IV Prodrug 509-511
Letairis ambrisentan 6/15/2007 Small Molecule Oral N.A. 512, 513
Selzentry maraviroc 8/6/2007 Small Molecule Oral N.A. 514-516
Ammonia N13 ammonia N-13 8/23/2007 Inorganic IV Drug Type 517
Somatuline Depot lanreotide 8/30/2007 Small Molecule IM
Subcutaneous Route
518
Doribax doripenem 10/12/2007 Small Molecule IV N.A. 519-521
Isentress raltegravir 10/12/2007 Small Molecule Oral N.A. 522-524
Ixempra ixabepilone 10/16/2007 Small Molecule IV N.A. 525, 526
Tasigna nilotinib 10/29/2007 Small Molecule Oral N.A. 527, 528
Mircera methoxy polyethylene glycol-epoetin
beta 11/14/2007 Protein
IV
Subcutaneous Drug Type
529
Kuvan sapropterin 12/13/2007 Small Molecule Oral No ADME Study 530, 531
Bystolic nebivolol 12/17/2007 Small Molecule Oral N.A. 532
Sutent sunitinib 1/26/2006 Small Molecule Oral N.A. 533-535
Ranexa ranolazine 1/27/2006 Small Molecule Oral N.A. 536-538
Amitiza lubiprostone 1/31/2006 Small Molecule Oral Insufficient Data 539
Eraxis anidulafungin 2/17/2006 Peptide IV Drug Type 540
Myozyme alglucosidase alfa 4/28/2006 Protein IV Drug Type 541
Dacogen decitabine 5/2/2006 Small Molecule IV N.A. 542, 543
Chantix varenicline 5/10/2006 Small Molecule Oral N.A. 544-546
Azilect rasagiline 5/16/2006 Small Molecule Oral Insufficient Data 547, 548
Prezista darunavir 6/23/2006 Small Molecule Oral N.A. 549-551
Sprycel dasatinib 6/28/2006 Small Molecule Oral N.A. 552-556
Lucentis ranibizumab 6/30/2006 Protein Intravitreal Drug Type 557
Anthelios SX
avobenzone (1992)
7/21/2006 Small Molecule
Combination Topical Route
558 ecamsule
octocrylene
Elaprase idursulfase 7/24/2006 Protein IV Drug Type 559
Noxafil posaconazole 9/15/2006 Small Molecule Oral N.A. 560-563
Vectibix panitumumab 9/27/2006 Protein IV Drug Type 564
Pylera
bismuth subcitrate potassium
9/28/2006 Small Molecule
Combination Oral No ADME Study
565 metronidazole (1959)
tetracycline (1953)
Zolinza vorinostat 10/6/2006 Small Molecule Oral Insufficient Data 566
Januvia sitagliptin 10/16/2006 Small Molecule Oral N.A. 567-569
Omnaris ciclesonide 10/20/2006 Small Molecule Nasal Spray Route 570
Tyzeka telbivudine 10/25/2006 Small Molecule Oral N.A. 571-573
Veregen sinecatechins 10/31/2006 Botanical Drug Topical Drug Type 574
Invega paliperidone 12/19/2006 Small Molecule Oral N.A. 575-577
N.A. – Not Applicable
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[462] FDA. (2008) Drug approval package: Cimzia (certolizumab). FDA application BLA 125160. FDA Silver Springs, MD.
[463] FDA. (2008) Drug approval package: Relistor (methylnaltrexone). FDA application NDA 021964. FDA Silver Springs, MD.
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[467] FDA. (2008) Drug approval package: Eovist (gadoxetate). FDA application NDA 022090. FDA Silver Springs, MD.
[468] FDA. (2008) Drug approval package: Cleviprex (clevidipine). FDA application NDA 022156. FDA Silver Springs, MD.
[469] FDA. (2008) Drug approval package: Xenazine (tetrabenazine). FDA application NDA 021894. FDA Silver Springs, MD.
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[473] FDA. (2008) Drug approval package: AdreView (iobenguane sulfate I-123). FDA application NDA 022290. FDA Silver
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[474] FDA. (2008) Drug approval package: Rapaflo (silodosin). FDA application NDA 022206. FDA Silver Springs, MD.
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[478] FDA. (2008) Drug approval package: Vimpat (lacosamide). FDA application NDA 022253. FDA Silver Springs, MD.
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[484] EMA. (2007) Human medicines: Toviaz (fesoterodine) Agency product number: EMEA/H/C/000723. London, UK.
[485] FDA. (2008) Drug approval package: Banzel (rufinamide). FDA application NDA 021911. FDA Silver Springs, MD.
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tapentadol HCl in healthy male subjects, European journal of drug metabolism and pharmacokinetics 32, 163-169.
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[494] FDA. (2008) Drug approval package: Mozobil (plerixafor). FDA application NDA 022311. FDA Silver Springs, MD.
[495] FDA. (2008) Drug approval package: Ablavar (gadofosveset). FDA application NDA 021711. FDA Silver Springs, MD.
[496] FDA. (2008) Drug approval package: Firmagon (degarelix). FDA application NDA 022201. FDA Silver Springs, MD.
[497] FDA. (2007) Drug approval package: Vyvanse (lisdexamfetamine dimesylate). FDA application NDA 021977. FDA Silver
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[498] FDA. (2007) Drug approval package: Tekturna (aliskiren). FDA application NDA 021985. FDA Silver Springs, MD.
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[506] FDA. (2007) Drug approval package: Soliris (eculizumab). FDA application BLA 125166. FDA Silver Springs, MD.
[507] FDA. (2007) Drug approval package: Altabax (retapamulin). FDA application NDA 022055. FDA Silver Springs, MD.
[508] FDA. (2007) Drug approval package: Neupro (rotigotine). FDA application NDA 021829. FDA Silver Springs, MD.
[509] FDA. (2007) Drug approval package: Torisel (temsirolimus). FDA application NDA 022088. FDA Silver Springs, MD.
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[512] FDA. (2007) Drug approval package: Letairis (ambrisentan). FDA application NDA 022081. FDA Silver Springs, MD.
[513] EMA. (2008) Human medicines: Volibris (ambrisentan) Agency product number: EMEA/H/C/000839. London, UK.
[514] FDA. (2007) Drug approval package: Selzentry (maraviroc). FDA application NDA 022128. FDA Silver Springs, MD.
[515] Abel, S., Russell, D., Whitlock, L. A., Ridgway, C. E., Nedderman, A. N., and Walker, D. K. (2008) Assessment of the
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[517] FDA. (2007) Drug approval package: Ammonia N13 (ammonia N-13). FDA application NDA 022119. FDA Silver Springs,
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[518] FDA. (2007) Drug approval package: Somatuline Depot (lanreotide). FDA application NDA 022074. FDA Silver Springs,
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[519] FDA. (2007) Drug approval package: Doribax (doripenem). FDA application NDA 022106. FDA Silver Springs, MD.
[520] Cirillo, I., Mannens, G., Janssen, C., Vermeir, M., Cuyckens, F., Desai-Krieger, D., Vaccaro, N., Kao, L. M., Devineni, D.,
Redman, R., and Turner, K. (2008) Disposition, metabolism, and excretion of [14C]doripenem after a single 500-milligram
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[523] Kassahun, K., McIntosh, I., Cui, D., Hreniuk, D., Merschman, S., Lasseter, K., Azrolan, N., Iwamoto, M., Wagner, J. A., and
Wenning, L. A. (2007) Metabolism and disposition in humans of raltegravir (MK-0518), an anti-AIDS drug targeting the
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[525] FDA. (2007) Drug approval package: Ixempra (ixabepilone). FDA application NDA 022065. FDA Silver Springs, MD.
[526] Comezoglu, S. N., Ly, V. T., Zhang, D., Humphreys, W. G., Bonacorsi, S. J., Everett, D. W., Cohen, M. B., Gan, J., Beumer, J.
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plasma, urine and feces samples using accelerator mass spectrometry (AMS), Drug metabolism and pharmacokinetics 24, 511-
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[529] FDA. (2007) Drug approval package: Mircera (methoxy polyethylene glycol-epoetin beta). FDA application BLA 125164.
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[530] FDA. (2007) Drug approval package: Kuvan (sapropterin). FDA application NDA 022181. FDA Silver Springs, MD.
[531] EMA. (2008) Human medicines: Kuvan (sapropterin) Agency product number: EMEA/H/C/000943. London, UK.
[532] FDA. (2007) Drug approval package: Bystolic (nebivolol). FDA application NDA 021742. FDA Silver Springs, MD.
[533] FDA. (2006) Drug approval package: Sutent (sunitinib). FDA application NDA 021938. FDA Silver Springs, MD.
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fate of chemicals 40, 539-555.
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[536] FDA. (2006) Drug approval package: Ranexa (ranolazine). FDA application NDA 021526. FDA Silver Springs, MD.
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[539] FDA. (2006) Drug approval package: Amitiza (lubiprostone). FDA application NDA 021908. FDA Silver Springs, MD.
[540] FDA. (2006) Drug approval package: Eraxis (anidulafungin). FDA application NDA 021632. FDA Silver Springs, MD.
[541] FDA. (2006) Drug approval package: Myozyme (alglucosidase alfa). FDA application BLA 125141. FDA Silver Springs,
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[542] FDA. (2006) Drug approval package: Dacogen (decitabine). FDA application NDA 021790. FDA Silver Springs, MD.
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[544] FDA. (2006) Drug approval package: Chantix (varenicline). FDA application NDA 021928. FDA Silver Springs, MD.
[545] Obach, R. S., Reed-Hagen, A. E., Krueger, S. S., Obach, B. J., O'Connell, T. N., Zandi, K. S., Miller, S., and Coe, J. W. (2006)
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[546] EMA. (2006) Human medicines: Champix (varenicline) Agency product number: EMEA/H/C/000699. London, UK.
[547] FDA. (2006) Drug approval package: Azilect (rasagiline). FDA application NDA 021641. FDA Silver Springs, MD.
[548] EMA. (2005) Human medicines: Azilect (rasagiline) Agency product number: EMEA/H/C/000574. London, UK.
[549] FDA. (2006) Drug approval package: Prezista (darunavir). FDA application NDA 021976. FDA Silver Springs, MD.
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excretion of darunavir, a new protease inhibitor, administered alone and with low-dose ritonavir in healthy subjects, Drug
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[552] FDA. (2006) Drug approval package: Sprycel (dasatinib). FDA application NDA 021986. FDA Silver Springs, MD.
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Galbraith, S., Reitberg, D. P., He, K., Barros, A., Jr., Blackwood-Chirchir, A., Humphreys, W. G., and Iyer, R. A. (2008)
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enzymes involved in the oxidative metabolism of dasatinib: an effective approach for determining metabolite formation
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[557] FDA. (2006) Drug approval package: Lucentis (ranibizumab). FDA application BLA 125156. FDA Silver Springs, MD.
[558] FDA. (2006) Drug approval package: Anthelios SX (avobenzone, ecamsule, and octocrylene). FDA application NDA 021502.
FDA Silver Springs, MD.
[559] FDA. (2006) Drug approval package: Elaprase (idursulfase). FDA application BLA 125151. FDA Silver Springs, MD.
[560] FDA. (2006) Drug approval package: Noxafil (posaconazole). FDA application NDA 022003. FDA Silver Springs, MD.
[561] Krieter, P., Flannery, B., Musick, T., Gohdes, M., Martinho, M., and Courtney, R. (2004) Disposition of Posaconazole following
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[563] EMA. (2005) Human medicines: Noxafil (posaconazole) Agency product number: EMEA/H/C/000610. London, UK.
[564] FDA. (2006) Drug approval package: Vectibix (panitumumab). FDA application BLA 125147. FDA Silver Springs, MD.
[565] FDA. (2006) Drug approval package: Pylera (biskalcitrate, metronidazole, and tetracycline ). FDA application NDA 050786.
FDA Silver Springs, MD.
[566] FDA. (2006) Drug approval package: Zolinza (vorinostat). FDA application NDA 021991. FDA Silver Springs, MD.
[567] FDA. (2006) Drug approval package: Januvia (sitagliptin phosphate). FDA application NDA 021995. FDA Silver Springs,
MD.
[568] Vincent, S. H., Reed, J. R., Bergman, A. J., Elmore, C. S., Zhu, B., Xu, S., Ebel, D., Larson, P., Zeng, W., Chen, L., Dilzer, S.,
Lasseter, K., Gottesdiener, K., Wagner, J. A., and Herman, G. A. (2007) Metabolism and excretion of the dipeptidyl peptidase
4 inhibitor [14C]sitagliptin in humans, Drug metabolism and disposition: the biological fate of chemicals 35, 533-538.
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[570] FDA. (2006) Drug approval package: Omnaris (ciclesonide). FDA application NDA 022004. FDA Silver Springs, MD.
[571] FDA. (2006) Drug approval package: Tyzeka (telbivudine). FDA application NDA 022011. FDA Silver Springs, MD.
[572] Zhou, X.-J., Lim, S.-G., Lloyd, D. M., Chao, G. C., Brown, N. A., and Lai, C.-L. (2006) Pharmacokinetics of Telbivudine
following Oral Administration of Escalating Single and Multiple Doses in Patients with Chronic Hepatitis B Virus Infection:
Pharmacodynamic Implications, Antimicrobial agents and chemotherapy 50, 874-879.
[573] EMA. (2007) Human medicines: Sebivo (telbivudine) Agency product number: EMEA/H/C/000713. London, UK.
[574] FDA. (2006) Drug approval package: Veregen (sinecatechins). FDA application NDA 021902. FDA Silver Springs, MD.
[575] FDA. (2006) Drug approval package: Invega (paliperidone). FDA application NDA 021999. FDA Silver Springs, MD.
[576] Vermeir, M., Naessens, I., Remmerie, B., Mannens, G., Hendrickx, J., Sterkens, P., Talluri, K., Boom, S., Eerdekens, M., van
Osselaer, N., and Cleton, A. (2008) Absorption, metabolism, and excretion of paliperidone, a new monoaminergic antagonist,
in humans, Drug metabolism and disposition: the biological fate of chemicals 36, 769-779.
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