prevalence of non-cytochrome p450-mediated...

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


Combination Oral N.A.

31, 32

ivacaftor (2012)

Entresto sacubitril


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)


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)


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


Combination Oral

N.A. 129, 130

sofosbuvir (2013)

Akynzeo netupitant



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



145, 146

ritonavir (1996)

dasabuvir

ombitasvir

Zerbaxa ceftolozane


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)


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)



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


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



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



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


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)



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



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


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)


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



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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[559] FDA. (2006) Drug approval package: Elaprase (idursulfase). FDA application BLA 125151. FDA Silver Springs, MD.

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[566] FDA. (2006) Drug approval package: Zolinza (vorinostat). FDA application NDA 021991. FDA Silver Springs, MD.

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Lasseter, K., Gottesdiener, K., Wagner, J. A., and Herman, G. A. (2007) Metabolism and excretion of the dipeptidyl peptidase

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[571] FDA. (2006) Drug approval package: Tyzeka (telbivudine). FDA application NDA 022011. FDA Silver Springs, MD.

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Osselaer, N., and Cleton, A. (2008) Absorption, metabolism, and excretion of paliperidone, a new monoaminergic antagonist,

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prevalence of non-cytochrome p450-mediated...

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