pirfenidone 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
4224 53179-13-8

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • pirfenidone
  • esbriet
  • glaspia
pyridone, indicated for the treatment of idiopathic pulmonary fibrosis
  • Molecular weight: 185.23
  • Formula: C12H11NO
  • CLOGP: 2.10
  • LIPINSKI: 0
  • HAC: 2
  • HDO: 0
  • TPSA: 20.31
  • ALOGS: -1.81
  • ROTB: 1
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
2.40 g O

ADMET properties:

PropertyValueReference
fu (Fraction unbound in plasma) 0.39 % Kawashima H, Watanabe R, Esaki T, Kuroda M, Nagao C, Natsume-Kitatani Y, Ohashi R, Komura H, Mizuguchi K

Approvals:

DateAgencyCompanyOrphan
Sept. 16, 2008 PMDA
Feb. 28, 2011 EMA Roche Registration Limited
Oct. 15, 2014 FDA GENENTECH INC

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Death 804.09 27.00 607 10894 373774 63103747
Nausea 413.42 27.00 626 10875 853845 62623676
Decreased appetite 318.12 27.00 302 11199 250750 63226771
Weight decreased 155.25 27.00 219 11282 276579 63200942
No adverse event 154.03 27.00 95 11406 41310 63436211
Dyspepsia 148.35 27.00 133 11368 102063 63375458
Cough 140.13 27.00 215 11286 292528 63184993
Pulmonary function test abnormal 133.14 27.00 36 11465 1794 63475727
Photosensitivity reaction 131.68 27.00 61 11440 14933 63462588
Forced vital capacity decreased 121.24 27.00 30 11471 1049 63476472
Dyspnoea 120.00 27.00 324 11177 660989 62816532
Oxygen saturation decreased 118.18 27.00 110 11391 88475 63389046
Pulmonary function test decreased 113.75 27.00 38 11463 3909 63473612
Dizziness 97.97 27.00 230 11271 429695 63047826
Lung diffusion test decreased 96.83 27.00 23 11478 675 63476846
Fatigue 95.93 27.00 364 11137 887664 62589857
Vomiting 81.70 27.00 254 11247 559363 62918158
Diarrhoea 78.47 27.00 295 11206 715071 62762450
Abdominal discomfort 76.60 27.00 175 11326 320710 63156811
Gastric disorder 71.33 27.00 57 11444 37312 63440209
Therapy interrupted 62.99 27.00 50 11451 32405 63445116
Pneumonia 62.56 27.00 203 11298 456564 63020957
Sunburn 61.56 27.00 22 11479 2766 63474755
Therapy cessation 55.03 27.00 45 11456 30412 63447109
Gastrooesophageal reflux disease 50.91 27.00 74 11427 95565 63381956
Amblyopia 48.59 27.00 11 11490 260 63477261
Drug ineffective 43.57 27.00 77 11424 1044688 62432833
Dyspnoea exertional 43.30 27.00 54 11447 60248 63417273
Flatulence 42.22 27.00 41 11460 34661 63442860
Malaise 38.46 27.00 163 11338 415791 63061730
Abdominal pain upper 37.92 27.00 102 11399 206342 63271179
Insomnia 36.22 27.00 103 11398 215149 63262372
Joint swelling 35.44 27.00 8 11493 327658 63149863
Interstitial lung disease 34.53 27.00 49 11452 61859 63415662
Asthenia 32.14 27.00 146 11355 383458 63094063
Arthropathy 31.65 27.00 3 11498 234789 63242732
Skin reaction 31.24 27.00 24 11477 14825 63462696
Upper respiratory tract congestion 29.79 27.00 12 11489 2090 63475431
Cystitis 28.44 27.00 42 11459 54949 63422572
Hospitalisation 27.94 27.00 53 11448 85028 63392493
Acute kidney injury 27.35 27.00 7 11494 263408 63214113

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Death 2328.96 23.77 1919 19776 396130 34539106
Decreased appetite 609.90 23.77 625 21070 165767 34769469
Photosensitivity reaction 433.00 23.77 183 21512 10411 34924825
Weight decreased 302.76 23.77 453 21242 175848 34759388
Dyspnoea 259.75 23.77 657 21038 376125 34559111
Sunburn 249.23 23.77 77 21618 1746 34933490
Nausea 242.74 23.77 601 21094 339307 34595929
Fatigue 233.39 23.77 625 21070 370028 34565208
Pulmonary function test abnormal 229.84 23.77 79 21616 2531 34932705
Pulmonary function test decreased 220.16 23.77 91 21604 4884 34930352
Cough 217.32 23.77 357 21338 149783 34785453
Abdominal discomfort 212.89 23.77 222 21473 59613 34875623
Dyspepsia 211.17 23.77 178 21517 36554 34898682
Rash 202.79 23.77 434 21261 222318 34712918
Oxygen saturation decreased 174.27 23.77 190 21505 53628 34881608
Forced vital capacity decreased 150.67 23.77 43 21652 733 34934503
Therapy interrupted 121.66 23.77 86 21609 13611 34921625
Lung transplant 120.93 23.77 46 21649 1978 34933258
No adverse event 111.35 23.77 101 21594 22826 34912410
Gastric disorder 110.23 23.77 78 21617 12363 34922873
Acute kidney injury 106.48 23.77 29 21666 304959 34630277
Dizziness 102.66 23.77 333 21362 218188 34717048
Lung diffusion test decreased 101.05 23.77 30 21665 591 34934645
Abdominal pain upper 93.79 23.77 163 21532 71327 34863909
Asthenia 92.05 23.77 347 21348 244904 34690332
Gastrooesophageal reflux disease 91.16 23.77 115 21580 37809 34897427
Pulmonary fibrosis 87.28 23.77 80 21615 18316 34916920
Dysgeusia 81.26 23.77 91 21604 26406 34908830
Toxicity to various agents 75.81 23.77 16 21679 200346 34734890
Pyrexia 75.49 23.77 58 21637 332955 34602281
Therapy cessation 71.30 23.77 69 21626 16904 34918332
Febrile neutropenia 65.92 23.77 5 21690 136844 34798392
Oesophageal pain 64.39 23.77 23 21672 826 34934410
Pruritus 64.37 23.77 214 21481 141767 34793469
Idiopathic pulmonary fibrosis 64.17 23.77 35 21660 3499 34931737
Dyspnoea exertional 54.53 23.77 97 21598 43182 34892054
Neutropenia 54.41 23.77 15 21680 156763 34778473
Thrombocytopenia 54.13 23.77 15 21680 156232 34779004
Pneumonia 54.08 23.77 397 21298 362230 34573006
Heart rate increased 53.49 23.77 100 21595 46243 34888993
Malaise 53.06 23.77 242 21453 185583 34749653
Painful respiration 52.61 23.77 22 21673 1214 34934022
Anorectal discomfort 51.76 23.77 25 21670 1939 34933297
Chest injury 50.41 23.77 23 21672 1568 34933668
Eructation 49.80 23.77 33 21662 4698 34930538
Lung disorder 49.26 23.77 82 21613 34614 34900622
Productive cough 49.25 23.77 86 21609 37727 34897509
Gastrointestinal disorder 49.23 23.77 81 21614 33867 34901369
Completed suicide 48.97 23.77 3 21692 98165 34837071
Flatulence 48.89 23.77 63 21632 21135 34914101
Diarrhoea 47.76 23.77 408 21287 389504 34545732
Total lung capacity decreased 47.52 23.77 19 21676 934 34934302
Constipation 47.26 23.77 189 21506 136793 34798443
Oxygen consumption increased 47.26 23.77 21 21674 1345 34933891
Pancytopenia 47.19 23.77 3 21692 95154 34840082
Anaemia 45.15 23.77 47 21648 233288 34701948
Muscle strain 44.94 23.77 29 21666 3947 34931289
Sneezing 44.43 23.77 32 21663 5210 34930026
Walking aid user 43.31 23.77 22 21673 1902 34933334
Ageusia 41.59 23.77 41 21654 10267 34924969
Gastrointestinal motility disorder 39.87 23.77 23 21672 2561 34932675
Overdose 39.45 23.77 5 21690 91054 34844182
Food aversion 37.82 23.77 13 21682 416 34934820
Platelet count decreased 37.02 23.77 14 21681 119703 34815533
Feeling cold 36.89 23.77 39 21656 10600 34924636
Pulmonary artery dilatation 36.70 23.77 11 21684 224 34935012
Dry skin 36.70 23.77 68 21627 31219 34904017
Haemoglobin decreased 35.90 23.77 15 21680 120757 34814479
Appetite disorder 35.50 23.77 21 21674 2450 34932786
Skin exfoliation 35.20 23.77 62 21633 27370 34907866
International normalised ratio decreased 34.47 23.77 26 21669 4541 34930695
Product use in unapproved indication 34.28 23.77 15 21680 117484 34817752
White blood cell count decreased 33.34 23.77 9 21686 95436 34839800
Hypotension 33.23 23.77 54 21641 221595 34713641
Confusional state 32.69 23.77 25 21670 144135 34791101
Hypersomnia 31.99 23.77 39 21656 12368 34922868
Nasopharyngitis 31.22 23.77 105 21590 69863 34865373
Aortic aneurysm 31.21 23.77 29 21666 6750 34928486
Pulmonary pain 30.51 23.77 15 21680 1209 34934027
Ill-defined disorder 29.99 23.77 40 21655 13869 34921367
Blood creatinine increased 29.53 23.77 11 21684 94965 34840271
Rhinorrhoea 29.12 23.77 55 21640 25613 34909623
Hot flush 28.77 23.77 45 21650 18021 34917215
Septic shock 28.68 23.77 5 21690 71829 34863407
Jaw cyst 27.92 23.77 6 21689 28 34935208
Respiratory failure 27.00 23.77 136 21559 108436 34826800
Neuropathy peripheral 26.99 23.77 9 21686 83254 34851982
Hyponatraemia 26.69 23.77 9 21686 82682 34852554
Seizure 26.68 23.77 16 21679 104841 34830395
Tachycardia 26.05 23.77 10 21685 84762 34850474
Hospitalisation 25.92 23.77 86 21609 56816 34878420
Hypokalaemia 25.69 23.77 3 21692 58211 34877025
Forced vital capacity abnormal 25.54 23.77 4 21691 0 34935236
Arteriosclerosis coronary artery 25.54 23.77 35 21660 12450 34922786
Drug intolerance 25.35 23.77 88 21607 59482 34875754
Insomnia 25.03 23.77 129 21566 103778 34831458
Sepsis 24.55 23.77 41 21654 166520 34768716
Pulmonary hypertension 23.94 23.77 45 21650 20879 34914357

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Death 1682.68 22.91 1373 22817 565141 79155057
Decreased appetite 754.61 22.91 704 23486 341714 79378484
Photosensitivity reaction 387.69 22.91 168 24022 20959 79699239
Nausea 357.77 22.91 848 23342 956348 78763850
Pulmonary function test abnormal 343.48 22.91 101 24089 4043 79716155
Weight decreased 338.74 22.91 474 23716 354724 79365474
Pulmonary function test decreased 309.49 22.91 108 24082 7529 79712669
Dyspnoea 307.49 22.91 748 23442 856277 78863921
Dyspepsia 280.29 22.91 245 23945 108442 79611756
Oxygen saturation decreased 262.98 22.91 255 23935 128792 79591406
Cough 251.16 22.91 420 23770 366369 79353829
Fatigue 247.61 22.91 727 23463 929000 78791198
Forced vital capacity decreased 219.77 22.91 59 24131 1684 79718514
Sunburn 181.80 22.91 61 24129 3772 79716426
Lung diffusion test decreased 163.55 22.91 44 24146 1266 79718932
Dizziness 155.15 22.91 428 23762 526013 79194185
Abdominal discomfort 152.76 22.91 273 23917 250454 79469744
Asthenia 122.90 22.91 387 23803 511302 79208896
Dyspnoea exertional 118.50 22.91 139 24051 86934 79633264
Gastric disorder 114.07 22.91 93 24097 37340 79682858
Rash 113.76 22.91 409 23781 577949 79142249
Pneumonia 107.79 22.91 440 23750 659806 79060392
Gastrooesophageal reflux disease 103.15 22.91 142 24048 104104 79616094
Lung transplant 99.36 22.91 41 24149 4520 79715678
Flatulence 93.64 22.91 88 24102 42636 79677562
Acute kidney injury 86.90 22.91 25 24165 519379 79200819
Therapy cessation 81.61 22.91 77 24113 37485 79682713
Toxicity to various agents 76.82 22.91 17 24173 421523 79298675
Dysgeusia 75.64 22.91 90 24100 57087 79663111
Idiopathic pulmonary fibrosis 69.04 22.91 31 24159 4197 79716001
Abdominal pain upper 68.62 22.91 185 24005 223634 79496564
No adverse event 67.30 22.91 69 24121 37123 79683075
Diarrhoea 63.57 22.91 470 23720 880019 78840179
Eructation 60.54 22.91 39 24151 10870 79709328
Pyrexia 59.67 22.91 71 24119 678638 79041560
Malaise 58.43 22.91 298 23892 489571 79230627
Febrile neutropenia 57.71 22.91 3 24187 230996 79489202
Infusion related reaction 57.49 22.91 3 24187 230234 79489964
Constipation 56.10 22.91 201 23989 282849 79437349
Therapy interrupted 54.64 22.91 57 24133 31284 79688914
Pulmonary fibrosis 54.37 22.91 67 24123 44045 79676153
Anorectal discomfort 54.30 22.91 25 24165 3586 79716612
Ageusia 54.21 22.91 43 24147 16589 79703609
Chest injury 53.57 22.91 23 24167 2798 79717400
Oesophageal pain 53.24 22.91 26 24164 4253 79715945
Product use in unapproved indication 52.36 22.91 7 24183 250352 79469846
Walking aid user 50.77 22.91 34 24156 10114 79710084
Drug ineffective 50.13 22.91 165 24025 1080748 78639450
Painful respiration 46.04 22.91 22 24168 3431 79716767
Productive cough 44.71 22.91 89 24101 88242 79631956
Aortic aneurysm 43.95 22.91 29 24161 8417 79711781
Amblyopia 43.91 22.91 11 24179 237 79719961
Product use issue 43.55 22.91 6 24184 209816 79510382
Heart rate increased 43.38 22.91 106 24084 120618 79599580
Thrombocytopenia 42.07 22.91 14 24176 265245 79454953
Skin exfoliation 41.41 22.91 66 24124 55034 79665164
Respiratory failure 40.63 22.91 134 24056 180777 79539421
Condition aggravated 39.29 22.91 57 24133 501067 79219131
Solar dermatitis 39.10 22.91 10 24180 235 79719963
Pancytopenia 38.87 22.91 3 24187 165742 79554456
Neutropenia 37.90 22.91 20 24170 287690 79432508
Dry skin 37.44 22.91 71 24119 67924 79652274
Pruritus 36.92 22.91 225 23965 394423 79325775
Gastrointestinal motility disorder 36.75 22.91 23 24167 6099 79714099
Haemoptysis 36.60 22.91 63 24127 55936 79664262
Overdose 36.54 22.91 6 24184 184200 79535998
Pneumothorax 36.49 22.91 44 24146 28279 79691919
Muscle strain 36.17 22.91 27 24163 9528 79710670
Oxygen consumption increased 35.79 22.91 21 24169 4958 79715240
Pain 35.67 22.91 103 24087 703699 79016499
International normalised ratio decreased 35.55 22.91 25 24165 8045 79712153
Joint swelling 35.26 22.91 22 24168 288624 79431574
Treatment failure 35.08 22.91 5 24185 170481 79549717
Skin reaction 35.01 22.91 33 24157 16035 79704163
Vomiting 33.34 22.91 328 23862 665500 79054698
Insomnia 33.33 22.91 155 24035 245015 79475183
Sneezing 32.89 22.91 35 24155 19648 79700550
Pulmonary hypertension 32.62 22.91 55 24135 48025 79672173
Lung disorder 32.48 22.91 74 24116 80483 79639715
Interstitial lung disease 32.40 22.91 91 24099 112509 79607689
Alopecia 32.10 22.91 15 24175 231340 79488858
Food aversion 31.73 22.91 12 24178 1051 79719147
Therapeutic product effect decreased 31.06 22.91 6 24184 163857 79556341
Hypokalaemia 30.16 22.91 4 24186 144036 79576162
Musculoskeletal stiffness 29.99 22.91 8 24182 175000 79545198
Feeling cold 29.69 22.91 40 24150 28689 79691509
Haemochromatosis 28.95 22.91 12 24178 1338 79718860
Arthropathy 28.69 22.91 9 24181 177102 79543096
Hot flush 28.62 22.91 56 24134 54821 79665377
Exercise tolerance decreased 28.60 22.91 23 24167 9048 79711150
Arteriosclerosis coronary artery 28.57 22.91 31 24159 17785 79702413
Hypersomnia 28.34 22.91 35 24155 23051 79697147
White blood cell count decreased 28.04 22.91 11 24179 188277 79531921
Platelet count decreased 27.97 22.91 12 24178 194652 79525546
Anaemia 27.28 22.91 59 24131 444956 79275242
Confusional state 27.09 22.91 34 24156 317963 79402235
Hypoxia 26.39 22.91 80 24110 103163 79617035
Hospitalisation 25.97 22.91 75 24115 94161 79626037
Forced vital capacity abnormal 25.93 22.91 5 24185 29 79720169
Rheumatoid arthritis 25.30 22.91 16 24174 208454 79511744
Pulmonary artery dilatation 24.38 22.91 8 24182 461 79719737
Acute respiratory failure 24.34 22.91 55 24135 59486 79660712
Off label use 23.06 22.91 171 24019 907044 78813154

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L04AX05 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
IMMUNOSUPPRESSANTS
IMMUNOSUPPRESSANTS
Other immunosuppressants
FDA CS M0018236 Pyridones
MeSH PA D000700 Analgesics
MeSH PA D018712 Analgesics, Non-Narcotic
MeSH PA D000893 Anti-Inflammatory Agents
MeSH PA D000894 Anti-Inflammatory Agents, Non-Steroidal
MeSH PA D000970 Antineoplastic Agents
MeSH PA D018501 Antirheumatic Agents
MeSH PA D002491 Central Nervous System Agents
MeSH PA D018373 Peripheral Nervous System Agents
MeSH PA D018689 Sensory System Agents
FDA EPC N0000191420 Pyridone
CHEBI has role CHEBI:35475 non-steroidal anti-inflammatory agent
CHEBI has role CHEBI:35493 anti-pyretic

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Idiopathic pulmonary fibrosis indication 700250006 DOID:0050156
Severe hepatic impairment contraindication 59927004
Severe renal impairment contraindication 236423003
End stage renal failure contraindication 236435004
Fluvoxamine contraindication 372905008
End stage liver disease contraindication 708248004




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
267MG ESBRIET GENENTECH INC N022535 Oct. 15, 2014 RX CAPSULE ORAL 7767225 Sept. 22, 2026 METHOD OF ADMINISTERING PIRFENIDONE CAPSULES TO TREAT A FIBROTIC CONDITION
267MG ESBRIET GENENTECH INC N022535 Oct. 15, 2014 RX CAPSULE ORAL 7988994 Sept. 22, 2026 METHOD OF ADMINISTERING PIRFENIDONE CAPSULES TO TREAT A FIBROTIC CONDITION
267MG ESBRIET GENENTECH INC N022535 Oct. 15, 2014 RX CAPSULE ORAL 8753679 Sept. 22, 2026 METHOD OF ADMINISTERING PIRFENIDONE CAPSULES TO TREAT A FIBROTIC CONDITION
267MG ESBRIET GENENTECH INC N022535 Oct. 15, 2014 RX CAPSULE ORAL 7696236 Dec. 18, 2027 DOSE ESCALATION OVER 14 DAYS FOR TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS
267MG ESBRIET GENENTECH INC N022535 Oct. 15, 2014 RX CAPSULE ORAL 7767700 Dec. 18, 2027 DOSE ESCALATION OVER 14 DAYS FOR TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS
267MG ESBRIET GENENTECH INC N022535 Oct. 15, 2014 RX CAPSULE ORAL 8420674 Dec. 18, 2027 DOSE ESCALATION OVER 14 DAYS FOR TREATMENT OF A FIBROSIS CONDITION
267MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 7767700 Dec. 18, 2027 PIRFENIDONE DOSE ESCALATION REGIMEN FOR TREATMENT OF IPF AS 801 MG/DAY FOR DAYS 1-7 OF THE REGIMEN, 1602 MG/DAY FOR DAYS 8-14 OF THE REGIMEN, AND 2403 MG/DAY FOR AT LEAST DAY 15 OF THE REGIMEN
267MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8420674 Dec. 18, 2027 PIRFENIDONE DOSE ESCALATION REGIMEN FOR TREATMENT OF FIBROSIS AS 801 MG/DAY FOR DAYS 1-7 OF THE REGIMEN, 1602 MG/DAY FOR DAYS 8-14 OF THE REGIMEN, AND 2403 MG/DAY FOR AT LEAST DAY 15 OF THE REGIMEN
534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ESBRIET GENENTECH INC N208780 Jan. 11, 2017 DISCN TABLET ORAL 7767700 Dec. 18, 2027 PIRFENIDONE DOSE ESCALATION REGIMEN FOR TREATMENT OF IPF AS 801 MG/DAY FOR DAYS 1-7 OF THE REGIMEN, 1602 MG/DAY FOR DAYS 8-14 OF THE REGIMEN, AND 2403 MG/DAY FOR AT LEAST DAY 15 OF THE REGIMEN
534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ESBRIET GENENTECH INC N208780 Jan. 11, 2017 DISCN TABLET ORAL 8420674 Dec. 18, 2027 PIRFENIDONE DOSE ESCALATION REGIMEN FOR TREATMENT OF FIBROSIS AS 801 MG/DAY FOR DAYS 1-7 OF THE REGIMEN, 1602 MG/DAY FOR DAYS 8-14 OF THE REGIMEN, AND 2403 MG/DAY FOR AT LEAST DAY 15 OF THE REGIMEN
801MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 7767700 Dec. 18, 2027 PIRFENIDONE DOSE ESCALATION REGIMEN FOR TREATMENT OF IPF AS 801 MG/DAY FOR DAYS 1-7 OF THE REGIMEN, 1602 MG/DAY FOR DAYS 8-14 OF THE REGIMEN, AND 2403 MG/DAY FOR AT LEAST DAY 15 OF THE REGIMEN
801MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8420674 Dec. 18, 2027 PIRFENIDONE DOSE ESCALATION REGIMEN FOR TREATMENT OF FIBROSIS AS 801 MG/DAY FOR DAYS 1-7 OF THE REGIMEN, 1602 MG/DAY FOR DAYS 8-14 OF THE REGIMEN, AND 2403 MG/DAY FOR AT LEAST DAY 15 OF THE REGIMEN
267MG ESBRIET GENENTECH INC N022535 Oct. 15, 2014 RX CAPSULE ORAL 8383150 May 10, 2028 METHOD OF ADMINISTERING A GRANULATE FORMULATION OF 5-METHYL-1-PHENYL-2-(1H)-PYRIDONE AS RECITED IN CLAIM 1, TO TREAT IDIOPATHIC PULMONARY FIBROSIS
267MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8383150 May 10, 2028 METHOD OF ADMINISTERING A GRANULATE FORMULATION OF 5-METHYL-1-PHENYL-2-(1H)-PYRIDONE AS RECITED IN CLAIM 1, TO TREAT IDIOPATHIC PULMONARY FIBROSIS
534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ESBRIET GENENTECH INC N208780 Jan. 11, 2017 DISCN TABLET ORAL 8383150 May 10, 2028 METHOD OF ADMINISTERING A GRANULATE FORMULATION OF 5-METHYL-1-PHENYL-2-(1H)-PYRIDONE AS RECITED IN CLAIM 1, TO TREAT IDIOPATHIC PULMONARY FIBROSIS
801MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8383150 May 10, 2028 METHOD OF ADMINISTERING A GRANULATE FORMULATION OF 5-METHYL-1-PHENYL-2-(1H)-PYRIDONE AS RECITED IN CLAIM 1, TO TREAT IDIOPATHIC PULMONARY FIBROSIS
267MG ESBRIET GENENTECH INC N022535 Oct. 15, 2014 RX CAPSULE ORAL 7566729 April 22, 2029 DOSAGE MODIFICATION FOLLOWING ELEVATED LIVER ENZYMES IN TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS
267MG ESBRIET GENENTECH INC N022535 Oct. 15, 2014 RX CAPSULE ORAL 7635707 April 22, 2029 CONTINUED DOSING OR DOSAGE MODIFICATION FOLLOWING ELEVATED LIVER ENZYMES IN TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS
267MG ESBRIET GENENTECH INC N022535 Oct. 15, 2014 RX CAPSULE ORAL 8592462 April 22, 2029 CONTINUED DOSING OR DOSAGE MODIFICATION FOLLOWING ELEVATED LIVER ENZYMES IN TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS
267MG ESBRIET GENENTECH INC N022535 Oct. 15, 2014 RX CAPSULE ORAL 8609701 April 22, 2029 CONTINUED DOSING OR DOSAGE MODIFICATION FOLLOWING ELEVATED LIVER ENZYMES IN USE OF PIRFENIDONE
267MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 7566729 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION, BY ADMINISTERING SUB-2400 MG/DAY DOSE THEN FULL DAY DAILY DOSE IN TREATMENT OF IPF
267MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 7566729 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS ARE WITHIN LIMITS, THEN SUB-2400MG/DAY DOSE, THEN FULL DAILY DOSE IN TREATMENT OF IPF
267MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 7635707 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION, BY ADMINISTERING 801 MG/DAY FOLLOWED BY ADMINISTERING 1602 MG/DAY IN TREATMENT OF IPF
267MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 7635707 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS ARE WITHIN NORMAL LIMITS, FOLLOWED BY 801 MG/DAY, DOSE, THEN 1602 MG/DAY IN TREATMENT OF IPF
267MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 7635707 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS ARE WITHIN NORMAL LIMITS FOLLOWED BY ADMINISTERING 1602 MG/DAY IN TREATMENT OF IPF
267MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 7635707 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS ARE WITHIN NORMAL LIMITS, FOLLOWED BY ADMINISTERING FULL DAILY DOSE IN TREATMENT OF IPF
267MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 7635707 April 22, 2029 DOSING 1602 MG/DAY PIRFENIDONE FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION IN TREATMENT OF IPF
267MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 7635707 April 22, 2029 FULL DAILY DOSING FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION IN TREATMENT OF IPF
267MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8592462 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN BIOMARKER AST AND/OR ALT AFTER PIRFENIDONE ADMINISTRATION, BY ADMINISTERING SUB-1600 MG/DAY, FOLLOWING BY ADMINISTERING AT LEAST 1600 MG/DAY IN TREATMENT OF IPF
267MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8592462 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN BIOMARKER AST AND/OR ALT AFTER PIRFENIDONE ADMINISTRATION, BY ADMINISTERING SUB-2400MG/DAY DOSE, FOLLOWED BY ADMINISTERING 2403MG/DAY IN TREATMENT OF IPF
267MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8592462 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN BIOMARKER AST AND/OR ALT AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS OF LIVER FUNCTION ARE WITHIN NORMAL LIMITS, FOLLOWED BY FULL DAILY DOSE IN TREATMENT OF IPF
267MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8592462 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN BIOMARKER AST AND/OR ALT AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS OF LIVER FUNCTION ARE WITHIN NORMAL LIMITS, THEN AT LEAST 1600MG/DAY IN TREATMENT OF IPF
267MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8592462 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION, BY ADMINISTERING SUB-1600 MG/DAY DOSE, FOLLOWED BY ADMINISTERING AT LEAST 1600 MG/DAY DOSE IN TREATMENT OF IPF
267MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8592462 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS ARE WITHIN NORMAL LIMITS, FOLLOWED BY ADMINISTERING AT LEAST 1600 MG/DAY IN TREATMENT OF IPF
267MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8592462 April 22, 2029 DOSING 2403 MG/DAY PIRFENIDONE FOLLOWING GRADE 2 ABNORMALITY IN BIOMARKER AST AND/OR ALT AFTER PIRFENIDONE ADMINISTRATION IN TREATMENT OF IPF
267MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8592462 April 22, 2029 DOSING OF AT LEAST 1600 MG/DAY FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION IN TREATMENT OF IPF
267MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8592462 April 22, 2029 DOSING OF AT LEAST 1600 MG/DAY FOLLOWING GRADE 2 LIVER ABNORMALITY IN BIOMARKER AST AND/OR ALT AFTER PIRFENIDONE ADMINISTRATION IN TREATMENT OF IPF
267MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8609701 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN BIOMARKER ALT OR AST AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS OF LIVER FUNCTION ARE WITHIN NORMAL LIMITS, THEN SUB-1600 MG/DAY, THEN AT LEAST 1602 MG/DAY
267MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8609701 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER ALT OR AST AFTER PIRFENIDONE ADMINISTRATION, BY ADMINISTERING A SUB-1600 MG/DAY DOSE, FOLLOWED BY ADMINISTERING AT LEAST 1602 MG/DAY
267MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8609701 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER ALT OR AST AFTER PIRFENIDONE ADMINISTRATION, BY ADMINISTERING SUB-2400 MG/DAY DOSE, FOLLOWED BY FULL DAILY DOSE
267MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8609701 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER ALT OR AST AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE, FOLLOWED BY ADMINISTERING AT LEAST 1602 MG/DAY
267MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8609701 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER ALT OR AST AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS OF LIVER FUNCTION ARE WITHIN NORMAL LIMITS, FOLLOWED BY FULL DAILY DOSE
267MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8609701 April 22, 2029 DOSING AT LEAST 1602 MG/DAY FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER ALT OR AST AFTER PIRFENIDONE ADMINISTRATION
267MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8609701 April 22, 2029 FULL DAILY DOSING FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER ALT OR AST AFTER PIRFENIDONE ADMINISTRATION
534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ESBRIET GENENTECH INC N208780 Jan. 11, 2017 DISCN TABLET ORAL 7566729 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION, BY ADMINISTERING SUB-2400MG/DAY DOSE THEN FULL DAILY DOSE IN TREATMENT OF IPF
534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ESBRIET GENENTECH INC N208780 Jan. 11, 2017 DISCN TABLET ORAL 7566729 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS ARE WITHIN NORMAL LIMITS, THEN SUB-2400MG/DAY DOSE, THEN FULL DAILY DOSE IN TREATMENT OF IPF
534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ESBRIET GENENTECH INC N208780 Jan. 11, 2017 DISCN TABLET ORAL 7635707 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION, BY ADMINISTERING 801 MG/DAY FOLLOWED BY ADMINISTERING 1602 MG/DAY IN TREATMENT OF IPF
534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ESBRIET GENENTECH INC N208780 Jan. 11, 2017 DISCN TABLET ORAL 7635707 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS ARE WITHIN NORMAL LIMITS, FOLLOWED BY 801 MG/DAY, DOSE, THEN 1602 MG/DAY IN TREATMENT OF IPF
534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ESBRIET GENENTECH INC N208780 Jan. 11, 2017 DISCN TABLET ORAL 7635707 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS ARE WITHIN NORMAL LIMITS FOLLOWED BY ADMINISTERING 1602 MG/DAY IN TREATMENT OF IPF
534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ESBRIET GENENTECH INC N208780 Jan. 11, 2017 DISCN TABLET ORAL 7635707 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS ARE WITHIN NORMAL LIMITS, FOLLOWED BY ADMINISTERING FULL DAILY DOSE IN TREATMENT OF IPF
534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ESBRIET GENENTECH INC N208780 Jan. 11, 2017 DISCN TABLET ORAL 7635707 April 22, 2029 DOSING 1602 MG/DAY PIRFENIDONE FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION IN TREATMENT OF IPF
534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ESBRIET GENENTECH INC N208780 Jan. 11, 2017 DISCN TABLET ORAL 7635707 April 22, 2029 FULL DAILY DOSING FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION IN TREATMENT OF IPF
534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ESBRIET GENENTECH INC N208780 Jan. 11, 2017 DISCN TABLET ORAL 8592462 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN BIOMARKER AST AND/OR ALT AFTER PIRFENIDONE ADMINISTRATION, BY ADMINISTERING SUB-1600 MG/DAY, FOLLOWING BY ADMINISTERING AT LEAST 1600 MG/DAY IN TREATMENT OF IPF
534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ESBRIET GENENTECH INC N208780 Jan. 11, 2017 DISCN TABLET ORAL 8592462 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN BIOMARKER AST AND/OR ALT AFTER PIRFENIDONE ADMINISTRATION, BY ADMINISTERING SUB-2400MG/DAY DOSE, FOLLOWED BY ADMINISTERING 2403MG/DAY IN TREATMENT OF IPF
534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ESBRIET GENENTECH INC N208780 Jan. 11, 2017 DISCN TABLET ORAL 8592462 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN BIOMARKER AST AND/OR ALT AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS OF LIVER FUNCTION ARE WITHIN NORMAL LIMITS, FOLLOWED BY FULL DAILY DOSE IN TREATMENT OF IPF
534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ESBRIET GENENTECH INC N208780 Jan. 11, 2017 DISCN TABLET ORAL 8592462 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN BIOMARKER AST AND/OR ALT AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS OF LIVER FUNCTION ARE WITHIN NORMAL LIMITS, THEN AT LEAST 1600MG/DAY IN TREATMENT OF IPF
534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ESBRIET GENENTECH INC N208780 Jan. 11, 2017 DISCN TABLET ORAL 8592462 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION, BY ADMINISTERING SUB-1600 MG/DAY DOSE, FOLLOWED BY ADMINISTERING AT LEAST 1600 MG/DAY DOSE IN TREATMENT OF IPF
534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ESBRIET GENENTECH INC N208780 Jan. 11, 2017 DISCN TABLET ORAL 8592462 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS ARE WITHIN NORMAL LIMITS, FOLLOWED BY ADMINISTERING AT LEAST 1600 MG/DAY IN TREATMENT OF IPF
534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ESBRIET GENENTECH INC N208780 Jan. 11, 2017 DISCN TABLET ORAL 8592462 April 22, 2029 DOSING 2403 MG/DAY PIRFENIDONE FOLLOWING GRADE 2 ABNORMALITY IN BIOMARKER AST AND/OR ALT AFTER PIRFENIDONE ADMINISTRATION IN TREATMENT OF IPF
534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ESBRIET GENENTECH INC N208780 Jan. 11, 2017 DISCN TABLET ORAL 8592462 April 22, 2029 DOSING OF AT LEAST 1600 MG/DAY FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION IN TREATMENT OF IPF
534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ESBRIET GENENTECH INC N208780 Jan. 11, 2017 DISCN TABLET ORAL 8592462 April 22, 2029 DOSING OF AT LEAST 1600 MG/DAY FOLLOWING GRADE 2 LIVER ABNORMALITY IN BIOMARKER AST AND/OR ALT AFTER PIRFENIDONE ADMINISTRATION IN TREATMENT OF IPF
534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ESBRIET GENENTECH INC N208780 Jan. 11, 2017 DISCN TABLET ORAL 8609701 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN BIOMARKER ALT OR AST AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS OF LIVER FUNCTION ARE WITHIN NORMAL LIMITS, THEN SUB-1600 MG/DAY, THEN AT LEAST 1602 MG/DAY
534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ESBRIET GENENTECH INC N208780 Jan. 11, 2017 DISCN TABLET ORAL 8609701 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER ALT OR AST AFTER PIRFENIDONE ADMINISTRATION, BY ADMINISTERING A SUB-1600 MG/DAY DOSE, FOLLOWED BY ADMINISTERING AT LEAST 1602 MG/DAY
534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ESBRIET GENENTECH INC N208780 Jan. 11, 2017 DISCN TABLET ORAL 8609701 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER ALT OR AST AFTER PIRFENIDONE ADMINISTRATION, BY ADMINISTERING SUB-2400 MG/DAY DOSE, FOLLOWED BY FULL DAILY DOSE
534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ESBRIET GENENTECH INC N208780 Jan. 11, 2017 DISCN TABLET ORAL 8609701 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER ALT OR AST AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE, FOLLOWED BY ADMINISTERING AT LEAST 1602 MG/DAY
534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ESBRIET GENENTECH INC N208780 Jan. 11, 2017 DISCN TABLET ORAL 8609701 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER ALT OR AST AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS OF LIVER FUNCTION ARE WITHIN NORMAL LIMITS, FOLLOWED BY FULL DAILY DOSE
534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ESBRIET GENENTECH INC N208780 Jan. 11, 2017 DISCN TABLET ORAL 8609701 April 22, 2029 DOSING AT LEAST 1602 MG/DAY FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER ALT OR AST AFTER PIRFENIDONE ADMINISTRATION
534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ESBRIET GENENTECH INC N208780 Jan. 11, 2017 DISCN TABLET ORAL 8609701 April 22, 2029 FULL DAILY DOSING FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER ALT OR AST AFTER PIRFENIDONE ADMINISTRATION
801MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 7566729 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION, BY ADMINISTERING SUB-2400 MG/DAY DOSE THEN FULL DAY DAILY DOSE IN TREATMENT OF IPF
801MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 7566729 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS ARE WITHIN LIMITS, THEN SUB-2400MG/DAY DOSE, THEN FULL DAILY DOSE IN TREATMENT OF IPF
801MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 7635707 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION, BY ADMINISTERING 801 MG/DAY FOLLOWED BY ADMINISTERING 1602 MG/DAY IN TREATMENT OF IPF
801MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 7635707 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS ARE WITHIN NORMAL LIMITS, FOLLOWED BY 801 MG/DAY, DOSE, THEN 1602 MG/DAY IN TREATMENT OF IPF
801MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 7635707 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS ARE WITHIN NORMAL LIMITS FOLLOWED BY ADMINISTERING 1602 MG/DAY IN TREATMENT OF IPF
801MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 7635707 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS ARE WITHIN NORMAL LIMITS, FOLLOWED BY ADMINISTERING FULL DAILY DOSE IN TREATMENT OF IPF
801MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 7635707 April 22, 2029 DOSING 1602 MG/DAY PIRFENIDONE FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION IN TREATMENT OF IPF
801MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 7635707 April 22, 2029 FULL DAILY DOSING FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION IN TREATMENT OF IPF
801MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8592462 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN BIOMARKER AST AND/OR ALT AFTER PIRFENIDONE ADMINISTRATION, BY ADMINISTERING SUB-1600 MG/DAY, FOLLOWING BY ADMINISTERING AT LEAST 1600 MG/DAY IN TREATMENT OF IPF
801MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8592462 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN BIOMARKER AST AND/OR ALT AFTER PIRFENIDONE ADMINISTRATION, BY ADMINISTERING SUB-2400MG/DAY DOSE, FOLLOWED BY ADMINISTERING 2403MG/DAY IN TREATMENT OF IPF
801MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8592462 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN BIOMARKER AST AND/OR ALT AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS OF LIVER FUNCTION ARE WITHIN NORMAL LIMITS, FOLLOWED BY FULL DAILY DOSE IN TREATMENT OF IPF
801MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8592462 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN BIOMARKER AST AND/OR ALT AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS OF LIVER FUNCTION ARE WITHIN NORMAL LIMITS, THEN AT LEAST 1600MG/DAY IN TREATMENT OF IPF
801MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8592462 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION, BY ADMINISTERING SUB-1600 MG/DAY DOSE, FOLLOWED BY ADMINISTERING AT LEAST 1600 MG/DAY DOSE IN TREATMENT OF IPF
801MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8592462 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS ARE WITHIN NORMAL LIMITS, FOLLOWED BY ADMINISTERING AT LEAST 1600 MG/DAY IN TREATMENT OF IPF
801MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8592462 April 22, 2029 DOSING 2403 MG/DAY PIRFENIDONE FOLLOWING GRADE 2 ABNORMALITY IN BIOMARKER AST AND/OR ALT AFTER PIRFENIDONE ADMINISTRATION IN TREATMENT OF IPF
801MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8592462 April 22, 2029 DOSING OF AT LEAST 1600 MG/DAY FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION IN TREATMENT OF IPF
801MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8592462 April 22, 2029 DOSING OF AT LEAST 1600 MG/DAY FOLLOWING GRADE 2 LIVER ABNORMALITY IN BIOMARKER AST AND/OR ALT AFTER PIRFENIDONE ADMINISTRATION IN TREATMENT OF IPF
801MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8609701 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN BIOMARKER ALT OR AST AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS OF LIVER FUNCTION ARE WITHIN NORMAL LIMITS, THEN SUB-1600 MG/DAY, THEN AT LEAST 1602 MG/DAY
801MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8609701 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER ALT OR AST AFTER PIRFENIDONE ADMINISTRATION, BY ADMINISTERING A SUB-1600 MG/DAY DOSE, FOLLOWED BY ADMINISTERING AT LEAST 1602 MG/DAY
801MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8609701 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER ALT OR AST AFTER PIRFENIDONE ADMINISTRATION, BY ADMINISTERING SUB-2400 MG/DAY DOSE, FOLLOWED BY FULL DAILY DOSE
801MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8609701 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER ALT OR AST AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE, FOLLOWED BY ADMINISTERING AT LEAST 1602 MG/DAY
801MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8609701 April 22, 2029 DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER ALT OR AST AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS OF LIVER FUNCTION ARE WITHIN NORMAL LIMITS, FOLLOWED BY FULL DAILY DOSE
801MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8609701 April 22, 2029 DOSING AT LEAST 1602 MG/DAY FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER ALT OR AST AFTER PIRFENIDONE ADMINISTRATION
801MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8609701 April 22, 2029 FULL DAILY DOSING FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER ALT OR AST AFTER PIRFENIDONE ADMINISTRATION
267MG ESBRIET GENENTECH INC N022535 Oct. 15, 2014 RX CAPSULE ORAL 7816383 Jan. 8, 2030 METHOD FOR ADMINISTERING PIRFENIDONE TO REDUCE DRUG INTERACTIONS WITH FLUVOXAMINE
267MG ESBRIET GENENTECH INC N022535 Oct. 15, 2014 RX CAPSULE ORAL 7910610 Jan. 8, 2030 METHOD FOR ADMINISTERING PIRFENIDONE TO REDUCE DRUG INTERACTIONS WITH A STRONG INHIBITOR OF CYP1A2
267MG ESBRIET GENENTECH INC N022535 Oct. 15, 2014 RX CAPSULE ORAL 8013002 Jan. 8, 2030 METHOD FOR ADMINISTERING PIRFENIDONE TO REDUCE DRUG INTERACTIONS WITH FLUVOXAMINE
267MG ESBRIET GENENTECH INC N022535 Oct. 15, 2014 RX CAPSULE ORAL 8084475 Jan. 8, 2030 METHOD FOR ADMINISTERING PIRFENIDONE TO AVOID REDUCED EFFICACY BY DISCONTINUING SMOKING OR BY DISCONTINUING OR AVOIDING ANOTHER STRONG CYP1A2 INDUCER
267MG ESBRIET GENENTECH INC N022535 Oct. 15, 2014 RX CAPSULE ORAL 8318780 Jan. 8, 2030 METHOD FOR ADMINISTERING PIRFENIDONE WHILE AVOIDING OR DISCONTINUING CONCOMITANT USE OF A MODERATE TO STRONG INHIBITOR OF BOTH CYP1A2 AND ANOTHER CYP ENZYME INVOLVED IN PIRFENIDONE METABOLISM
267MG ESBRIET GENENTECH INC N022535 Oct. 15, 2014 RX CAPSULE ORAL 8648098 Jan. 8, 2030 METHOD FOR ADMINISTERING PIRFENIDONE TO AVOID REDUCED EFFICACY BY DISCONTINUING SMOKING OR BY DISCONTINUING A STRONG CYP1A2 INDUCER
267MG ESBRIET GENENTECH INC N022535 Oct. 15, 2014 RX CAPSULE ORAL 8754109 Jan. 8, 2030 METHOD FOR ADMINISTERING PIRFENIDONE TO AVOID REDUCED EFFICACY BY AVOIDING SMOKING OR BY AVOIDING ANOTHER STRONG CYP1A2 INDUCER
267MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 7816383 Jan. 8, 2030 ADMINISTERING PIRFENIDONE WHILE AVOIDING CO-ADMINISTRATION OF FLUVOXAMINE TO AVOID DRUG INTERACTIONS WITH PIRFENIDONE
267MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 7816383 Jan. 8, 2030 DISCONTINUING ADMINISTRATION OF FLUVOXAMINE TO AVOID DRUG INTERACTIONS WITH PIRFENIDONE AND THEN ADMINISTERING PIRFENIDONE
267MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 7910610 Jan. 8, 2030 ADMINISTERING PIRFENIDONE WHILE AVOIDING CO-ADMINISTRATION OF A STRONG CYP1A2 INHIBITOR TO AVOID DRUG INTERACTIONS WITH PIRFENIDONE
267MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 7910610 Jan. 8, 2030 DISCONTINUING ADMINISTRATION OF A STRONG CYP1A2 INHIBITOR TO AVOID DRUG INTERACTIONS WITH PIRFENIDONE AND THEN ADMINISTERING PIRFENIDONE
267MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8013002 Jan. 8, 2030 ADMINISTERING PIRFENIDONE CONCURRENTLY WITH FLUVOXAMINE, THE PIRFENIDONE AT A DOSE OF ABOUT 801 MG/DAY TO REDUCE DRUG INTERACTIONS WITH FLUVOXAMINE
267MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8013002 Jan. 8, 2030 MODIFYING PIRFENIDONE ADMINISTRATION FROM A DOSE OF ABOUT 2400 MG/DAY DOWNWARD BY ABOUT 1600 MG/DAY WHILE CO-ADMINISTERING FLUVOXAMINE TO REDUCE DRUG INTERACTIONS WITH FLUVOXAMINE
267MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8084475 Jan. 8, 2030 ADMINISTERING PIRFENIDONE WHILE AVOIDING CONCOMITANT ADMINISTRATION OF A STRONG INDUCER OF CYP1A2 TO AVOID REDUCED PIRFENIDONE EFFICACY
267MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8084475 Jan. 8, 2030 DISCONTINUING ADMINISTRATION OF A STRONG CYP1A2 INDUCER TO AVOID REDUCED PIRFENIDONE EFFICACY AND THEN ADMINISTERING PIRFENIDONE
267MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8318780 Jan. 8, 2030 ADMINISTERING PIRFENIDONE WHILE AVOIDING CONCOMITANT USE OF A CYP1A2 INHIBITOR THAT IS A MODERATE TO STRONG INHIBITOR OF BOTH CYP1A2 AND ANOTHER CYP ENZYME SELECTED FROM CYP2C9, CYP2C19, AND CYP2D6
267MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8318780 Jan. 8, 2030 DISCONTINUING USE OF A CYP1A2 INHIBITOR THAT IS A MODERATE TO STRONG INHIBITOR OF BOTH CYP1A2 AND ANOTHER CYP ENZYME SELECTED FROM CYP2C9, CYP2C19, AND CYP2D6 AND THEN ADMINISTERING PIRFENIDONE
267MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8648098 Jan. 8, 2030 DISCONTINUING ADMINISTRATION OF A STRONG CYP1A2 INDUCER TO AVOID REDUCED PIRFENIDONE EFFICACY AND THEN ADMINISTERING PIRFENIDONE
267MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8648098 Jan. 8, 2030 DISCONTINUING SMOKING TO AVOID REDUCED PIRFENIDONE EFFICACY AND THEN ADMINISTERING PIRFENIDONE
267MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8754109 Jan. 8, 2030 ADMINISTERING PIRFENIDONE WHILE AVOIDING CONCOMITANT ADMINISTRATION OF A STRONG INDUCER OF CYP1A2, INCLUDING CIGARETTE SMOKE, TO AVOID REDUCED PIRFENIDONE EFFICACY
534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ESBRIET GENENTECH INC N208780 Jan. 11, 2017 DISCN TABLET ORAL 7816383 Jan. 8, 2030 ADMINISTERING PIRFENIDONE WHILE AVOIDING CO-ADMINISTRATION OF FLUVOXAMINE TO AVOID DRUG INTERACTIONS WITH PIRFENIDONE
534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ESBRIET GENENTECH INC N208780 Jan. 11, 2017 DISCN TABLET ORAL 7816383 Jan. 8, 2030 DISCONTINUING ADMINISTRATION OF FLUVOXAMINE TO AVOID DRUG INTERACTIONS WITH PIRFENIDONE AND THEN ADMINISTERING PIRFENIDONE
534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ESBRIET GENENTECH INC N208780 Jan. 11, 2017 DISCN TABLET ORAL 7910610 Jan. 8, 2030 ADMINISTERING PIRFENIDONE WHILE AVOIDING CO-ADMINISTRATION OF A STRONG CYP1A2 INHIBITOR TO AVOID DRUG INTERACTIONS WITH PIRFENIDONE
534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ESBRIET GENENTECH INC N208780 Jan. 11, 2017 DISCN TABLET ORAL 7910610 Jan. 8, 2030 DISCONTINUING ADMINISTRATION OF A STRONG CYP1A2 INHIBITOR TO AVOID DRUG INTERACTIONS WITH PIRFENIDONE AND THEN ADMINISTERING PIRFENIDONE
534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ESBRIET GENENTECH INC N208780 Jan. 11, 2017 DISCN TABLET ORAL 8013002 Jan. 8, 2030 ADMINISTERING PIRFENIDONE CONCURRENTLY WITH FLUVOXAMINE, THE PIRFENIDONE AT A DOSE OF ABOUT 801 MG/DAY TO REDUCE DRUG INTERACTIONS WITH FLUVOXAMINE
534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ESBRIET GENENTECH INC N208780 Jan. 11, 2017 DISCN TABLET ORAL 8013002 Jan. 8, 2030 MODIFYING PIRFENIDONE ADMINISTRATION FROM A DOSE OF ABOUT 2400 MG/DAY DOWNWARD BY ABOUT 1600 MG/DAY WHILE CO-ADMINISTERING FLUVOXAMINE TO REDUCE DRUG INTERACTIONS WITH FLUVOXAMINE
534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ESBRIET GENENTECH INC N208780 Jan. 11, 2017 DISCN TABLET ORAL 8084475 Jan. 8, 2030 ADMINISTERING PIRFENIDONE WHILE AVOIDING CONCOMITANT ADMINISTRATION OF A STRONG INDUCER OF CYP1A2 TO AVOID REDUCED PIRFENIDONE EFFICACY
534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ESBRIET GENENTECH INC N208780 Jan. 11, 2017 DISCN TABLET ORAL 8084475 Jan. 8, 2030 DISCONTINUING A STRONG CYP1A2 INDUCER TO AVOID REDUCED PIRFENIDONE EFFICACY AND THEN ADMINISTERING PIRFENIDONE
534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ESBRIET GENENTECH INC N208780 Jan. 11, 2017 DISCN TABLET ORAL 8318780 Jan. 8, 2030 ADMINISTERING PIRFENIDONE WHILE AVOIDING CONCOMITANT USE OF A CYP1A2 INHIBITOR THAT IS A MODERATE TO STRONG INHIBITOR OF BOTH CYP1A2 AND ANOTHER CYP ENZYME SELECTED FROM CYP2C9, CYP2C19, AND CYP2D6
534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ESBRIET GENENTECH INC N208780 Jan. 11, 2017 DISCN TABLET ORAL 8318780 Jan. 8, 2030 DISCONTINUING USE OF A CYP1A2 INHIBITOR THAT IS A MODERATE TO STRONG INHIBITOR OF BOTH CYP1A2 AND ANOTHER CYP ENZYME SELECTED FROM CYP2C9, CYP2C19, AND CYP2D6 AND THEN ADMINISTERING PIRFENIDONE
534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ESBRIET GENENTECH INC N208780 Jan. 11, 2017 DISCN TABLET ORAL 8648098 Jan. 8, 2030 DISCONTINUING ADMINISTRATION OF A STRONG CYP1A2 INDUCER TO AVOID REDUCED PIRFENIDONE EFFICACY AND THEN ADMINISTERING PIRFENIDONE
534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ESBRIET GENENTECH INC N208780 Jan. 11, 2017 DISCN TABLET ORAL 8648098 Jan. 8, 2030 DISCONTINUING SMOKING TO AVOID REDUCED PIRFENIDONE EFFICACY AND THEN ADMINISTERING PIRFENIDONE
534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ESBRIET GENENTECH INC N208780 Jan. 11, 2017 DISCN TABLET ORAL 8754109 Jan. 8, 2030 ADMINISTERING PIRFENIDONE WHILE AVOIDING CONCOMITANT ADMINISTRATION OF A STRONG INDUCER OF CYP1A2, INCLUDING CIGARETTE SMOKE, TO AVOID REDUCED PIRFENIDONE EFFICACY
801MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 7816383 Jan. 8, 2030 ADMINISTERING PIRFENIDONE WHILE AVOIDING CO-ADMINISTRATION OF FLUVOXAMINE TO AVOID DRUG INTERACTIONS WITH PIRFENIDONE
801MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 7816383 Jan. 8, 2030 DISCONTINUING ADMINISTRATION OF FLUVOXAMINE TO AVOID DRUG INTERACTIONS WITH PIRFENIDONE AND THEN ADMINISTERING PIRFENIDONE
801MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 7910610 Jan. 8, 2030 ADMINISTERING PIRFENIDONE WHILE AVOIDING CO-ADMINISTRATION OF A STRONG CYP1A2 INHIBITOR TO AVOID DRUG INTERACTIONS WITH PIRFENIDONE
801MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 7910610 Jan. 8, 2030 DISCONTINUING ADMINISTRATION OF A STRONG CYP1A2 INHIBITOR TO AVOID DRUG INTERACTIONS WITH PIRFENIDONE AND THEN ADMINISTERING PIRFENIDONE
801MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8013002 Jan. 8, 2030 ADMINISTERING PIRFENIDONE CONCURRENTLY WITH FLUVOXAMINE, THE PIRFENIDONE AT A DOSE OF ABOUT 801 MG/DAY TO REDUCE DRUG INTERACTIONS WITH FLUVOXAMINE
801MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8013002 Jan. 8, 2030 MODIFYING PIRFENIDONE ADMINISTRATION FROM A DOSE OF ABOUT 2400 MG/DAY DOWNWARD BY ABOUT 1600 MG/DAY WHILE CO-ADMINISTERING FLUVOXAMINE TO REDUCE DRUG INTERACTIONS WITH FLUVOXAMINE
801MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8084475 Jan. 8, 2030 ADMINISTERING PIRFENIDONE WHILE AVOIDING CONCOMITANT ADMINISTRATION OF A STRONG INDUCER OF CYP1A2 TO AVOID REDUCED PIRFENIDONE EFFICACY
801MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8084475 Jan. 8, 2030 DISCONTINUING ADMINISTRATION OF A STRONG CYP1A2 INDUCER TO AVOID REDUCED PIRFENIDONE EFFICACY AND THEN ADMINISTERING PIRFENIDONE
801MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8318780 Jan. 8, 2030 ADMINISTERING PIRFENIDONE WHILE AVOIDING CONCOMITANT USE OF A CYP1A2 INHIBITOR THAT IS A MODERATE TO STRONG INHIBITOR OF BOTH CYP1A2 AND ANOTHER CYP ENZYME SELECTED FROM CYP2C9, CYP2C19, AND CYP2D6
801MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8318780 Jan. 8, 2030 DISCONTINUING USE OF A CYP1A2 INHIBITOR THAT IS A MODERATE TO STRONG INHIBITOR OF BOTH CYP1A2 AND ANOTHER CYP ENZYME SELECTED FROM CYP2C9, CYP2C19, AND CYP2D6 AND THEN ADMINISTERING PIRFENIDONE
801MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8648098 Jan. 8, 2030 DISCONTINUING ADMINISTRATION OF A STRONG CYP1A2 INDUCER TO AVOID REDUCED PIRFENIDONE EFFICACY AND THEN ADMINISTERING PIRFENIDONE
801MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8648098 Jan. 8, 2030 DISCONTINUING SMOKING TO AVOID REDUCED PIRFENIDONE EFFICACY AND THEN ADMINISTERING PIRFENIDONE
801MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8754109 Jan. 8, 2030 ADMINISTERING PIRFENIDONE WHILE AVOIDING CONCOMITANT ADMINISTRATION OF A STRONG INDUCER OF CYP1A2, INCLUDING CIGARETTE SMOKE, TO AVOID REDUCED PIRFENIDONE EFFICACY
267MG ESBRIET GENENTECH INC N022535 Oct. 15, 2014 RX CAPSULE ORAL 8778947 Aug. 30, 2033 DOSAGE MODIFICATION IN TREATMENT WITH PIRFENIDONE TO REDUCE DRUG INTERACTIONS WITH CIPROFLOXACIN
267MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8778947 Aug. 30, 2033 ADMINISTRATION OF PIRFENIDONE AND AVOIDING CONCURRENT ADMINISTRATION OF CIPROFLOXACIN AT A DOSE OF 750 MG TO REDUCE DRUG INTERACTIONS IN TREATMENT OF A FIBROTIC, INFLAMMATORY, OR AUTOIMMUNE DISORDER
267MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8778947 Aug. 30, 2033 DOSE REDUCTION OF PIRFENIDONE BY ABOUT ONE HALF DURING CONCURRENT ADMINISTRATION OF CIPROFLOXACIN AT A DOSE OF 750 MG TWICE DAILY (1500 MG/DAY) TO REDUCE DRUG INTERACTIONS IN TREATMENT OF A FIBROTIC, INFLAMMATORY, OR AUTOIMMUNE DISORDER
534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ESBRIET GENENTECH INC N208780 Jan. 11, 2017 DISCN TABLET ORAL 8778947 Aug. 30, 2033 ADMINISTRATION OF PIRFENIDONE AND AVOIDING CONCURRENT ADMINISTRATION OF CIPROFLOXACIN AT A DOSE OF 750 MG TO REDUCE DRUG INTERACTIONS IN TREATMENT OF A FIBROTIC, INFLAMMATORY, OR AUTOIMMUNE DISORDER
534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ESBRIET GENENTECH INC N208780 Jan. 11, 2017 DISCN TABLET ORAL 8778947 Aug. 30, 2033 DOSE REDUCTION OF PIRFENIDONE BY ABOUT ONE HALF DURING CONCURRENT ADMINISTRATION OF CIPROFLOXACIN AT A DOSE OF 750 MG TWICE DAILY (1500 MG/DAY) TO REDUCE DRUG INTERACTIONS IN TREATMENT OF A FIBROTIC, INFLAMMATORY, OR AUTOIMMUNE DISORDER
801MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8778947 Aug. 30, 2033 ADMINISTRATION OF PIRFENIDONE AND AVOIDING CONCURRENT ADMINISTRATION OF CIPROFLOXACIN AT A DOSE OF 750 MG TO REDUCE DRUG INTERACTIONS IN TREATMENT OF A FIBROTIC, INFLAMMATORY, OR AUTOIMMUNE DISORDER
801MG ESBRIET GENENTECH INC N208780 Jan. 11, 2017 RX TABLET ORAL 8778947 Aug. 30, 2033 DOSE REDUCTION OF PIRFENIDONE BY ABOUT ONE HALF DURING CONCURRENT ADMINISTRATION OF CIPROFLOXACIN AT A DOSE OF 750 MG TWICE DAILY (1500 MG/DAY) TO REDUCE DRUG INTERACTIONS IN TREATMENT OF A FIBROTIC, INFLAMMATORY, OR AUTOIMMUNE DISORDER

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

None

External reference:

IDSource
4033815 VUID
N0000191097 NUI
D01583 KEGG_DRUG
4033815 VANDF
C0298067 UMLSCUI
CHEBI:32016 CHEBI
CHEMBL1256391 ChEMBL_ID
DB04951 DRUGBANK_ID
C093844 MESH_SUPPLEMENTAL_RECORD_UI
7532 IUPHAR_LIGAND_ID
3825 INN_ID
D7NLD2JX7U UNII
40632 PUBCHEM_CID
1592254 RXNORM
198886 MMSL
29209 MMSL
354385 MMSL
d08031 MMSL
014994 NDDF
438240001 SNOMEDCT_US
439581000 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Pirfenidone HUMAN PRESCRIPTION DRUG LABEL 1 0480-3610 TABLET, FILM COATED 267 mg ORAL ANDA 27 sections
Pirfenidone HUMAN PRESCRIPTION DRUG LABEL 1 0480-3611 TABLET, FILM COATED 801 mg ORAL ANDA 27 sections
Pirfenidone HUMAN PRESCRIPTION DRUG LABEL 1 0781-2158 CAPSULE 267 mg ORAL ANDA 28 sections
Pirfenidone HUMAN PRESCRIPTION DRUG LABEL 1 0781-8085 TABLET, FILM COATED 267 mg ORAL ANDA 28 sections
Pirfenidone HUMAN PRESCRIPTION DRUG LABEL 1 0781-8085 TABLET, FILM COATED 267 mg ORAL ANDA 28 sections
Pirfenidone HUMAN PRESCRIPTION DRUG LABEL 1 0781-8086 TABLET, FILM COATED 801 mg ORAL ANDA 28 sections
Pirfenidone HUMAN PRESCRIPTION DRUG LABEL 1 0781-8086 TABLET, FILM COATED 801 mg ORAL ANDA 28 sections
PIRFENIDONE HUMAN PRESCRIPTION DRUG LABEL 1 16729-467 TABLET, FILM COATED 267 mg ORAL ANDA 28 sections
PIRFENIDONE HUMAN PRESCRIPTION DRUG LABEL 1 16729-467 TABLET, FILM COATED 267 mg ORAL ANDA 28 sections
PIRFENIDONE HUMAN PRESCRIPTION DRUG LABEL 1 16729-468 TABLET, FILM COATED 801 mg ORAL ANDA 28 sections
PIRFENIDONE HUMAN PRESCRIPTION DRUG LABEL 1 16729-468 TABLET, FILM COATED 801 mg ORAL ANDA 28 sections
Pirfenidone HUMAN PRESCRIPTION DRUG LABEL 1 31722-872 TABLET, FILM COATED 267 mg ORAL ANDA 26 sections
Pirfenidone HUMAN PRESCRIPTION DRUG LABEL 1 31722-872 TABLET, FILM COATED 267 mg ORAL ANDA 26 sections
Pirfenidone HUMAN PRESCRIPTION DRUG LABEL 1 31722-873 TABLET, FILM COATED 801 mg ORAL ANDA 26 sections
Pirfenidone HUMAN PRESCRIPTION DRUG LABEL 1 31722-873 TABLET, FILM COATED 801 mg ORAL ANDA 26 sections
Pirfenidone Human Prescription Drug Label 1 42385-923 CAPSULE 267 mg ORAL ANDA 27 sections
Pirfenidone Human Prescription Drug Label 1 42385-923 CAPSULE 267 mg ORAL ANDA 27 sections
Pirfenidone Human Prescription Drug Label 1 42385-924 TABLET, FILM COATED 267 mg ORAL ANDA 27 sections
Pirfenidone Human Prescription Drug Label 1 42385-924 TABLET, FILM COATED 267 mg ORAL ANDA 27 sections
Pirfenidone Human Prescription Drug Label 1 42385-925 TABLET, FILM COATED 534 mg ORAL ANDA 27 sections
Pirfenidone Human Prescription Drug Label 1 42385-925 TABLET, FILM COATED 534 mg ORAL ANDA 27 sections
Pirfenidone Human Prescription Drug Label 1 42385-926 TABLET, FILM COATED 801 mg ORAL ANDA 27 sections
Pirfenidone Human Prescription Drug Label 1 42385-926 TABLET, FILM COATED 801 mg ORAL ANDA 27 sections
Pirfenidone HUMAN PRESCRIPTION DRUG LABEL 1 42571-335 TABLET, FILM COATED 267 mg ORAL ANDA 27 sections
Pirfenidone HUMAN PRESCRIPTION DRUG LABEL 1 42571-336 TABLET, FILM COATED 801 mg ORAL ANDA 27 sections
Pirfenidone Human Prescription Drug Label 1 46708-479 TABLET, COATED 267 mg ORAL ANDA 27 sections
Pirfenidone Human Prescription Drug Label 1 46708-480 TABLET, COATED 801 mg ORAL ANDA 27 sections
PIRFENIDONE HUMAN PRESCRIPTION DRUG LABEL 1 50228-441 CAPSULE 267 mg ORAL ANDA 27 sections
PIRFENIDONE HUMAN PRESCRIPTION DRUG LABEL 1 50228-442 TABLET 267 mg ORAL ANDA 27 sections
PIRFENIDONE HUMAN PRESCRIPTION DRUG LABEL 1 50228-443 TABLET 801 mg ORAL ANDA 27 sections