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pirfenidone 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| 4224 | 53179-13-8 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
pyridone, indicated for the treatment of idiopathic pulmonary fibrosis
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 2.40 | g | O |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| 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 |
| BA (Bioavailability) | 80 % |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| azlogd74 | LogD at pH 7.4 | 1.124 | High | 1 | |
| caco2-efflux | Caco-2 efflux ratio (BA/AB) | 0.465 | High | 1 | |
| caco2-intrinsic-papp | Caco-2 intrinsic apparent permeability | 87.700 | 10^-6 cm/s | High | 1 |
| dh-clint | Dog hepatocyte intrinsic clearance | 3.890 | uL/min/10^6 cells | High | 1 |
| dppb | Dog plasma protein binding (% unbound) | 67.380 | % | High | 1 |
| fcs-ppb | Fetal calf serum protein binding (% unbound) | 67.120 | % | High | 1 |
| herg | hERG pIC50 | 3.841 | pIC50 | High | 1 |
| hh-clint | Human hepatocyte intrinsic clearance | 1.191 | uL/min/10^6 cells | High | 1 |
| hlm-clint | Human liver microsomal intrinsic clearance | 3.141 | uL/min/mg protein | High | 1 |
| hppb | Human plasma protein binding (% unbound) | 65.270 | % | High | 1 |
| kinase-safety-class | ACVR2B,AXL,CAMK2D,CDK5,CDK9,EIF2AK3,ERBB2,GRK2,ITK,MAPK7,PDK1,PDK4,STK33 | 13 | |||
| kinase-selectivity-class | AXL,ERBB2,GRK2 | 3 | |||
| mdck-mdr1-bcrp-efflux | MDCK-MDR1-BCRP efflux ratio | 0.782 | High | 1 | |
| mdck-mdr1-efflux | MDCK-MDR1 efflux ratio | 0.828 | High | 1 | |
| mh-clint | Mouse hepatocyte intrinsic clearance | 9.661 | High | 1 | |
| mppb | Mouse plasma protein binding (% unbound) | 67.780 | High | 1 | |
| nih-mdck-mdr1-efflux | NIH MDCK-MDR1 efflux ratio | 0.899 | High | 1 | |
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 | |||
| pppb | Pig plasma protein binding (% unbound) | 80.940 | % | High | 1 |
| rat-kpuu-brain | Rat brain Kpuu | 1.089 | % | High | 1 |
| rh-clint | Rat hepatocyte intrinsic clearance | 2.761 | uL/min/10^6 cells | High | 1 |
| rh-fuinc | Rat hepatocyte fraction unbound in incubation | 94.790 | % | High | 1 |
| rppb | Rat plasma protein binding (% unbound) | 56.520 | % | High | 1 |
| solubility-dd | Solubility at pH 7.4 in DMSO | 790.679 | uM | High | 1 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| 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 term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Death | 1013.35 | 25.34 | 686 | 12166 | 455865 | 90159730 |
| Nausea | 474.17 | 25.34 | 674 | 12178 | 1109642 | 89505953 |
| Decreased appetite | 314.62 | 25.34 | 323 | 12529 | 376217 | 90239378 |
| No adverse event | 215.80 | 25.34 | 129 | 12723 | 67853 | 90547742 |
| Cough | 168.62 | 25.34 | 233 | 12619 | 368729 | 90246866 |
| Weight decreased | 161.86 | 25.34 | 232 | 12620 | 379678 | 90235917 |
| Photosensitivity reaction | 158.63 | 25.34 | 68 | 12784 | 17739 | 90597856 |
| Dyspnoea | 145.98 | 25.34 | 358 | 12494 | 880597 | 89734998 |
| Pulmonary function test decreased | 143.04 | 25.34 | 44 | 12808 | 4450 | 90611145 |
| Forced vital capacity decreased | 141.65 | 25.34 | 33 | 12819 | 1145 | 90614450 |
| Oxygen saturation decreased | 137.11 | 25.34 | 117 | 12735 | 107366 | 90508229 |
| Pulmonary function test abnormal | 127.49 | 25.34 | 36 | 12816 | 2703 | 90612892 |
| Dyspepsia | 119.92 | 25.34 | 144 | 12708 | 198016 | 90417579 |
| Lung diffusion test decreased | 109.07 | 25.34 | 25 | 12827 | 806 | 90614789 |
| Fatigue | 107.36 | 25.34 | 382 | 12470 | 1153641 | 89461954 |
| Dizziness | 104.21 | 25.34 | 246 | 12606 | 589038 | 90026557 |
| Diarrhoea | 99.57 | 25.34 | 325 | 12527 | 938865 | 89676730 |
| Vomiting | 87.22 | 25.34 | 277 | 12575 | 788016 | 89827579 |
| Gastric disorder | 87.19 | 25.34 | 56 | 12796 | 33328 | 90582267 |
| Pneumonia | 82.53 | 25.34 | 237 | 12615 | 637822 | 89977773 |
| Therapy cessation | 80.44 | 25.34 | 55 | 12797 | 36306 | 90579289 |
| Therapy interrupted | 73.09 | 25.34 | 59 | 12793 | 50049 | 90565546 |
| Interstitial lung disease | 67.86 | 25.34 | 68 | 12784 | 76337 | 90539258 |
| Sunburn | 67.30 | 25.34 | 23 | 12829 | 3244 | 90612351 |
| Abdominal discomfort | 65.22 | 25.34 | 181 | 12671 | 477147 | 90138448 |
| Amblyopia | 60.52 | 25.34 | 13 | 12839 | 309 | 90615286 |
| Dyspnoea exertional | 51.13 | 25.34 | 57 | 12795 | 72231 | 90543364 |
| Gastrooesophageal reflux disease | 47.70 | 25.34 | 85 | 12767 | 166252 | 90449343 |
| Flatulence | 44.63 | 25.34 | 41 | 12811 | 41326 | 90574269 |
| Joint swelling | 43.89 | 25.34 | 9 | 12843 | 503291 | 90112304 |
| Drug ineffective | 41.50 | 25.34 | 84 | 12768 | 1384214 | 89231381 |
| Malaise | 39.52 | 25.34 | 176 | 12676 | 585810 | 90029785 |
| Upper respiratory tract congestion | 38.60 | 25.34 | 14 | 12838 | 2348 | 90613247 |
| Arthropathy | 37.77 | 25.34 | 4 | 12848 | 366238 | 90249357 |
| Hospitalisation | 37.40 | 25.34 | 66 | 12786 | 128034 | 90487561 |
| Systemic lupus erythematosus | 37.20 | 25.34 | 4 | 12848 | 361892 | 90253703 |
| Skin reaction | 33.94 | 25.34 | 25 | 12827 | 18528 | 90597067 |
| Asthenia | 33.50 | 25.34 | 157 | 12695 | 533594 | 90082001 |
| Cystitis | 33.14 | 25.34 | 44 | 12808 | 66674 | 90548921 |
| Abdominal pain upper | 33.05 | 25.34 | 113 | 12739 | 332561 | 90283034 |
| Forced vital capacity abnormal | 32.52 | 25.34 | 6 | 12846 | 63 | 90615532 |
| Ageusia | 32.46 | 25.34 | 23 | 12829 | 16053 | 90599542 |
| Respiratory failure | 32.00 | 25.34 | 59 | 12793 | 118359 | 90497236 |
| Idiopathic pulmonary fibrosis | 31.72 | 25.34 | 11 | 12841 | 1619 | 90613976 |
| Product use in unapproved indication | 31.48 | 25.34 | 5 | 12847 | 336231 | 90279364 |
| Productive cough | 31.09 | 25.34 | 46 | 12806 | 77017 | 90538578 |
| Rash | 29.92 | 25.34 | 204 | 12648 | 795896 | 89819699 |
| Treatment failure | 29.65 | 25.34 | 4 | 12848 | 303924 | 90311671 |
| Insomnia | 29.46 | 25.34 | 109 | 12743 | 333365 | 90282230 |
| Pneumothorax | 28.85 | 25.34 | 23 | 12829 | 19144 | 90596451 |
| Pharyngeal mass | 28.23 | 25.34 | 7 | 12845 | 317 | 90615278 |
| Solar dermatitis | 27.38 | 25.34 | 6 | 12846 | 157 | 90615438 |
| Swelling | 26.75 | 25.34 | 13 | 12839 | 419045 | 90196550 |
| Pyrexia | 26.38 | 25.34 | 33 | 12819 | 660452 | 89955143 |
| Lung transplant | 26.11 | 25.34 | 12 | 12840 | 3680 | 90611915 |
FDA Adverse Event Reporting System (Male)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Death | 2659.73 | 22.72 | 2139 | 21946 | 469046 | 42128204 |
| Decreased appetite | 621.50 | 22.72 | 648 | 23437 | 192489 | 42404761 |
| Photosensitivity reaction | 517.19 | 22.72 | 213 | 23872 | 12489 | 42584761 |
| Weight decreased | 330.08 | 22.72 | 490 | 23595 | 207458 | 42389792 |
| Dyspnoea | 282.16 | 22.72 | 707 | 23378 | 441914 | 42155336 |
| Sunburn | 257.62 | 22.72 | 80 | 24005 | 2035 | 42595215 |
| Nausea | 255.91 | 22.72 | 637 | 23448 | 396162 | 42201088 |
| Pulmonary function test decreased | 242.99 | 22.72 | 99 | 23986 | 5633 | 42591617 |
| Pulmonary function test abnormal | 238.59 | 22.72 | 80 | 24005 | 2614 | 42594636 |
| Cough | 237.94 | 22.72 | 388 | 23697 | 177715 | 42419535 |
| Fatigue | 235.68 | 22.72 | 655 | 23430 | 434986 | 42162264 |
| Forced vital capacity decreased | 228.96 | 22.72 | 61 | 24024 | 879 | 42596371 |
| Dyspepsia | 227.93 | 22.72 | 188 | 23897 | 41164 | 42556086 |
| Abdominal discomfort | 199.80 | 22.72 | 229 | 23856 | 75026 | 42522224 |
| Rash | 195.47 | 22.72 | 461 | 23624 | 276493 | 42320757 |
| Oxygen saturation decreased | 189.08 | 22.72 | 207 | 23878 | 64480 | 42532770 |
| Lung diffusion test decreased | 167.39 | 22.72 | 47 | 24038 | 832 | 42596418 |
| Lung transplant | 135.68 | 22.72 | 51 | 24034 | 2335 | 42594915 |
| Therapy interrupted | 130.60 | 22.72 | 105 | 23980 | 22145 | 42575105 |
| Gastric disorder | 127.29 | 22.72 | 81 | 24004 | 11841 | 42585409 |
| No adverse event | 122.94 | 22.72 | 130 | 23955 | 38891 | 42558359 |
| Therapy cessation | 116.83 | 22.72 | 95 | 23990 | 20355 | 42576895 |
| Acute kidney injury | 112.70 | 22.72 | 34 | 24051 | 367303 | 42229947 |
| Dizziness | 112.19 | 22.72 | 352 | 23733 | 248902 | 42348348 |
| Idiopathic pulmonary fibrosis | 109.40 | 22.72 | 53 | 24032 | 4551 | 42592699 |
| Asthenia | 102.02 | 22.72 | 369 | 23716 | 280424 | 42316826 |
| Abdominal pain upper | 95.42 | 22.72 | 169 | 23916 | 82440 | 42514810 |
| Pulmonary fibrosis | 87.79 | 22.72 | 91 | 23994 | 26590 | 42570660 |
| Gastrooesophageal reflux disease | 85.61 | 22.72 | 116 | 23969 | 44907 | 42552343 |
| Febrile neutropenia | 84.93 | 22.72 | 5 | 24080 | 185698 | 42411552 |
| Pyrexia | 80.66 | 22.72 | 63 | 24022 | 393979 | 42203271 |
| Pneumonia | 74.45 | 22.72 | 449 | 23636 | 421700 | 42175550 |
| Dysgeusia | 72.58 | 22.72 | 93 | 23992 | 34096 | 42563154 |
| Toxicity to various agents | 70.53 | 22.72 | 21 | 24064 | 229115 | 42368135 |
| Thrombocytopenia | 63.16 | 22.72 | 15 | 24070 | 190264 | 42406986 |
| Oesophageal pain | 62.24 | 22.72 | 23 | 24062 | 1003 | 42596247 |
| Neutropenia | 61.87 | 22.72 | 18 | 24067 | 199413 | 42397837 |
| Gastrointestinal disorder | 61.14 | 22.72 | 101 | 23984 | 46552 | 42550698 |
| Dyspnoea exertional | 59.68 | 22.72 | 104 | 23981 | 50044 | 42547206 |
| Malaise | 58.48 | 22.72 | 256 | 23829 | 211900 | 42385350 |
| Heart rate increased | 57.68 | 22.72 | 106 | 23979 | 53149 | 42544101 |
| Restrictive pulmonary disease | 55.90 | 22.72 | 23 | 24062 | 1340 | 42595910 |
| Diarrhoea | 55.65 | 22.72 | 447 | 23638 | 460402 | 42136848 |
| Pancytopenia | 54.32 | 22.72 | 3 | 24082 | 117740 | 42479510 |
| Anaemia | 53.33 | 22.72 | 48 | 24037 | 280230 | 42317020 |
| Chest injury | 52.61 | 22.72 | 24 | 24061 | 1798 | 42595452 |
| Painful respiration | 52.43 | 22.72 | 22 | 24063 | 1347 | 42595903 |
| Hospice care | 51.69 | 22.72 | 41 | 24044 | 8472 | 42588778 |
| Oxygen consumption increased | 51.55 | 22.72 | 23 | 24062 | 1636 | 42595614 |
| Pruritus | 51.40 | 22.72 | 227 | 23858 | 188544 | 42408706 |
| Product use in unapproved indication | 51.36 | 22.72 | 20 | 24065 | 184436 | 42412814 |
| Anorectal discomfort | 50.70 | 22.72 | 25 | 24060 | 2230 | 42595020 |
| Forced vital capacity abnormal | 48.59 | 22.72 | 8 | 24077 | 4 | 42597246 |
| Ageusia | 48.26 | 22.72 | 45 | 24040 | 11560 | 42585690 |
| Eructation | 48.17 | 22.72 | 33 | 24052 | 5453 | 42591797 |
| Total lung capacity decreased | 47.68 | 22.72 | 28 | 24057 | 3542 | 42593708 |
| Constipation | 45.56 | 22.72 | 197 | 23888 | 162094 | 42435156 |
| Flatulence | 45.07 | 22.72 | 63 | 24022 | 25089 | 42572161 |
| Malignant neoplasm progression | 43.79 | 22.72 | 5 | 24080 | 108395 | 42488855 |
| Sneezing | 43.77 | 22.72 | 33 | 24052 | 6330 | 42590920 |
| Muscle strain | 43.69 | 22.72 | 29 | 24056 | 4548 | 42592702 |
| Respiratory failure | 43.49 | 22.72 | 165 | 23920 | 127967 | 42469283 |
| Acute respiratory failure | 42.89 | 22.72 | 78 | 24007 | 38780 | 42558470 |
| Completed suicide | 42.87 | 22.72 | 3 | 24082 | 96462 | 42500788 |
| Lung disorder | 42.87 | 22.72 | 88 | 23997 | 47835 | 42549415 |
| Gastrointestinal motility disorder | 41.91 | 22.72 | 24 | 24061 | 2897 | 42594353 |
| Productive cough | 41.85 | 22.72 | 91 | 23994 | 51476 | 42545774 |
| Walking aid user | 38.76 | 22.72 | 22 | 24063 | 2611 | 42594639 |
| Pulmonary artery dilatation | 38.45 | 22.72 | 12 | 24073 | 310 | 42596940 |
| Hospitalisation | 38 | 22.72 | 110 | 23975 | 74220 | 42523030 |
| International normalised ratio decreased | 36.63 | 22.72 | 26 | 24059 | 4546 | 42592704 |
| Food aversion | 36.54 | 22.72 | 13 | 24072 | 508 | 42596742 |
| Drug ineffective | 36.19 | 22.72 | 209 | 23876 | 629988 | 41967262 |
| Overdose | 35.49 | 22.72 | 8 | 24077 | 105256 | 42491994 |
| Confusional state | 35.20 | 22.72 | 26 | 24059 | 167571 | 42429679 |
| Haemoglobin decreased | 34.24 | 22.72 | 16 | 24069 | 132455 | 42464795 |
| Feeling cold | 33.54 | 22.72 | 39 | 24046 | 12934 | 42584316 |
| Appetite disorder | 33.46 | 22.72 | 21 | 24064 | 2994 | 42594256 |
| FEV1/FVC ratio decreased | 33.44 | 22.72 | 9 | 24076 | 135 | 42597115 |
| Rhabdomyolysis | 33.06 | 22.72 | 3 | 24082 | 78016 | 42519234 |
| Inappropriate schedule of product administration | 32.91 | 22.72 | 7 | 24078 | 95895 | 42501355 |
| Interstitial lung disease | 32.57 | 22.72 | 108 | 23977 | 78354 | 42518896 |
| Platelet count decreased | 32.48 | 22.72 | 19 | 24066 | 138562 | 42458688 |
| White blood cell count decreased | 32.35 | 22.72 | 11 | 24074 | 110385 | 42486865 |
| Pneumothorax | 32.22 | 22.72 | 52 | 24033 | 23491 | 42573759 |
| Aortic aneurysm | 32.21 | 22.72 | 30 | 24055 | 7693 | 42589557 |
| Blood creatinine increased | 32.17 | 22.72 | 11 | 24074 | 109992 | 42487258 |
| Neuropathy peripheral | 31.91 | 22.72 | 9 | 24076 | 101844 | 42495406 |
| Lung diffusion disorder | 31.75 | 22.72 | 9 | 24076 | 165 | 42597085 |
| Rhinorrhoea | 31.57 | 22.72 | 61 | 24024 | 31733 | 42565517 |
| Drug intolerance | 31.01 | 22.72 | 108 | 23977 | 80316 | 42516934 |
| Septic shock | 30.83 | 22.72 | 7 | 24078 | 91665 | 42505585 |
| Hypersomnia | 29.81 | 22.72 | 39 | 24046 | 14579 | 42582671 |
| Hypokalaemia | 29.75 | 22.72 | 3 | 24082 | 71718 | 42525532 |
| Lung diffusion test abnormal | 29.47 | 22.72 | 7 | 24078 | 61 | 42597189 |
| Ill-defined disorder | 29.46 | 22.72 | 41 | 24044 | 16255 | 42580995 |
| Seizure | 29.00 | 22.72 | 16 | 24069 | 120545 | 42476705 |
| Lung neoplasm malignant | 28.57 | 22.72 | 44 | 24041 | 19103 | 42578147 |
| Pulmonary pain | 28.24 | 22.72 | 15 | 24070 | 1563 | 42595687 |
| Hyponatraemia | 28.22 | 22.72 | 11 | 24074 | 101451 | 42495799 |
| Pulmonary hypertension | 28.18 | 22.72 | 49 | 24036 | 23520 | 42573730 |
| Tachycardia | 28.05 | 22.72 | 11 | 24074 | 101076 | 42496174 |
| Jaw cyst | 27.98 | 22.72 | 6 | 24079 | 31 | 42597219 |
| Product use issue | 27.60 | 22.72 | 5 | 24080 | 76746 | 42520504 |
| Insomnia | 27.56 | 22.72 | 136 | 23949 | 118117 | 42479133 |
| Hypotension | 27.50 | 22.72 | 66 | 24019 | 257565 | 42339685 |
| Nasopharyngitis | 26.70 | 22.72 | 106 | 23979 | 83890 | 42513360 |
| Exercise tolerance decreased | 26.14 | 22.72 | 24 | 24061 | 6042 | 42591208 |
| Skin exfoliation | 25.73 | 22.72 | 66 | 24019 | 41487 | 42555763 |
| Hot flush | 24.83 | 22.72 | 45 | 24040 | 22306 | 42574944 |
| Infusion related reaction | 24.07 | 22.72 | 3 | 24082 | 60803 | 42536447 |
| Haemochromatosis | 24.03 | 22.72 | 12 | 24073 | 1100 | 42596150 |
| Irregular breathing | 23.69 | 22.72 | 8 | 24077 | 267 | 42596983 |
| Hypoglycaemia | 23.58 | 22.72 | 3 | 24082 | 59851 | 42537399 |
| Solar dermatitis | 22.95 | 22.72 | 6 | 24079 | 80 | 42597170 |
FDA Adverse Event Reporting System (Geriatric)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Death | 2113.17 | 21.99 | 1571 | 25640 | 697298 | 109864790 |
| Decreased appetite | 756.16 | 21.99 | 744 | 26467 | 475102 | 110086986 |
| Photosensitivity reaction | 516.05 | 21.99 | 205 | 27006 | 25384 | 110536704 |
| Nausea | 413.16 | 21.99 | 923 | 26288 | 1234767 | 109327321 |
| Weight decreased | 380.56 | 21.99 | 519 | 26692 | 467538 | 110094550 |
| Pulmonary function test decreased | 361.53 | 21.99 | 119 | 27092 | 8581 | 110553507 |
| Dyspnoea | 356.17 | 21.99 | 815 | 26396 | 1106057 | 109456031 |
| Pulmonary function test abnormal | 350.03 | 21.99 | 102 | 27109 | 4898 | 110557190 |
| Forced vital capacity decreased | 303.71 | 21.99 | 75 | 27136 | 1895 | 110560193 |
| Oxygen saturation decreased | 302.47 | 21.99 | 274 | 26937 | 156708 | 110405380 |
| Cough | 296.37 | 21.99 | 458 | 26753 | 461183 | 110100905 |
| Fatigue | 259.30 | 21.99 | 768 | 26443 | 1215190 | 109346898 |
| Dyspepsia | 236.08 | 21.99 | 262 | 26949 | 190703 | 110371385 |
| Lung diffusion test decreased | 205.18 | 21.99 | 53 | 27158 | 1612 | 110560476 |
| Sunburn | 200.22 | 21.99 | 65 | 27146 | 4483 | 110557605 |
| Dizziness | 166.40 | 21.99 | 460 | 26751 | 697733 | 109864355 |
| Therapy cessation | 149.54 | 21.99 | 108 | 27103 | 44749 | 110517339 |
| Pneumonia | 147.90 | 21.99 | 512 | 26699 | 876202 | 109685886 |
| Gastric disorder | 145.98 | 21.99 | 95 | 27116 | 33262 | 110528826 |
| Dyspnoea exertional | 134.03 | 21.99 | 146 | 27065 | 103914 | 110458174 |
| Asthenia | 128.99 | 21.99 | 417 | 26794 | 688582 | 109873506 |
| Abdominal discomfort | 119.99 | 21.99 | 285 | 26926 | 393573 | 110168515 |
| Rash | 114.39 | 21.99 | 451 | 26760 | 820513 | 109741575 |
| Lung transplant | 108.76 | 21.99 | 43 | 27168 | 5243 | 110556845 |
| No adverse event | 108.22 | 21.99 | 111 | 27100 | 73728 | 110488360 |
| Idiopathic pulmonary fibrosis | 103.99 | 21.99 | 41 | 27170 | 4963 | 110557125 |
| Flatulence | 92.45 | 21.99 | 87 | 27124 | 52062 | 110510026 |
| Respiratory failure | 86.15 | 21.99 | 174 | 27037 | 215158 | 110346930 |
| Diarrhoea | 83.90 | 21.99 | 522 | 26689 | 1138983 | 109423105 |
| Infusion related reaction | 80.61 | 21.99 | 3 | 27208 | 381159 | 110180929 |
| Dysgeusia | 79.49 | 21.99 | 92 | 27119 | 69893 | 110492195 |
| Hospice care | 78.94 | 21.99 | 45 | 27166 | 12428 | 110549660 |
| Acute kidney injury | 78.79 | 21.99 | 29 | 27182 | 635401 | 109926687 |
| Interstitial lung disease | 77.73 | 21.99 | 130 | 27081 | 139204 | 110422884 |
| Acute respiratory failure | 77.33 | 21.99 | 94 | 27117 | 75166 | 110486922 |
| Ageusia | 76.41 | 21.99 | 52 | 27159 | 19593 | 110542495 |
| Product use in unapproved indication | 73.92 | 21.99 | 11 | 27200 | 447366 | 110114722 |
| Gastrooesophageal reflux disease | 73.85 | 21.99 | 147 | 27064 | 179829 | 110382259 |
| Pneumothorax | 66.66 | 21.99 | 61 | 27150 | 35224 | 110526864 |
| Therapy interrupted | 66.03 | 21.99 | 71 | 27140 | 49751 | 110512337 |
| Febrile neutropenia | 65.27 | 21.99 | 3 | 27208 | 316764 | 110245324 |
| Malaise | 61.17 | 21.99 | 326 | 26885 | 671493 | 109890595 |
| Pyrexia | 61.12 | 21.99 | 79 | 27132 | 898186 | 109663902 |
| Constipation | 60.01 | 21.99 | 209 | 27002 | 357577 | 110204511 |
| Toxicity to various agents | 59.42 | 21.99 | 22 | 27189 | 480533 | 110081555 |
| Forced vital capacity abnormal | 59.17 | 21.99 | 11 | 27200 | 65 | 110562023 |
| Drug ineffective | 58.10 | 21.99 | 187 | 27024 | 1520353 | 109041735 |
| Chest injury | 57.34 | 21.99 | 24 | 27187 | 3385 | 110558703 |
| Abdominal pain upper | 56.88 | 21.99 | 202 | 27009 | 348909 | 110213179 |
| Eructation | 56.55 | 21.99 | 38 | 27173 | 14019 | 110548069 |
| Anorectal discomfort | 56.12 | 21.99 | 25 | 27186 | 4101 | 110557987 |
| Heart rate increased | 54.86 | 21.99 | 114 | 27097 | 143720 | 110418368 |
| Oesophageal pain | 53.95 | 21.99 | 26 | 27185 | 5099 | 110556989 |
| Product use issue | 53.03 | 21.99 | 7 | 27204 | 311688 | 110250400 |
| Productive cough | 50.07 | 21.99 | 96 | 27115 | 114209 | 110447879 |
| Amblyopia | 49.29 | 21.99 | 12 | 27199 | 285 | 110561803 |
| Painful respiration | 48.72 | 21.99 | 22 | 27189 | 3725 | 110558363 |
| Aortic aneurysm | 47.77 | 21.99 | 30 | 27181 | 9874 | 110552214 |
| Treatment failure | 47.70 | 21.99 | 6 | 27205 | 277228 | 110284860 |
| Joint swelling | 47.29 | 21.99 | 25 | 27186 | 442820 | 110119268 |
| Solar dermatitis | 45.60 | 21.99 | 11 | 27200 | 251 | 110561837 |
| Systemic lupus erythematosus | 45.01 | 21.99 | 5 | 27206 | 254333 | 110307755 |
| Alopecia | 44.56 | 21.99 | 17 | 27194 | 364736 | 110197352 |
| Pulmonary hypertension | 44.24 | 21.99 | 61 | 27150 | 55159 | 110506929 |
| Thrombocytopenia | 43.06 | 21.99 | 16 | 27195 | 348869 | 110213219 |
| Oxygen consumption increased | 42.80 | 21.99 | 23 | 27188 | 5662 | 110556426 |
| Hypoxia | 41.81 | 21.99 | 96 | 27115 | 129419 | 110432669 |
| Therapeutic product effect decreased | 40.34 | 21.99 | 6 | 27205 | 244310 | 110317778 |
| Skin exfoliation | 40.09 | 21.99 | 75 | 27136 | 87576 | 110474512 |
| Pancytopenia | 40.09 | 21.99 | 3 | 27208 | 209610 | 110352478 |
| Exercise tolerance decreased | 40.07 | 21.99 | 29 | 27182 | 12038 | 110550050 |
| International normalised ratio decreased | 39.85 | 21.99 | 25 | 27186 | 8211 | 110553877 |
| Arthropathy | 39.34 | 21.99 | 11 | 27200 | 287511 | 110274577 |
| Pulmonary fibrosis | 39.04 | 21.99 | 81 | 27130 | 101961 | 110460127 |
| Haemoptysis | 39.00 | 21.99 | 66 | 27145 | 71288 | 110490800 |
| Vomiting | 38.53 | 21.99 | 367 | 26844 | 910308 | 109651780 |
| Wound | 38.15 | 21.99 | 6 | 27205 | 234431 | 110327657 |
| Musculoskeletal stiffness | 37.74 | 21.99 | 11 | 27200 | 279811 | 110282277 |
| Gastrointestinal motility disorder | 37.52 | 21.99 | 23 | 27188 | 7253 | 110554835 |
| Muscle strain | 37.38 | 21.99 | 27 | 27184 | 11175 | 110550913 |
| Neutropenia | 37.34 | 21.99 | 23 | 27188 | 374597 | 110187491 |
| Confusional state | 36.37 | 21.99 | 37 | 27174 | 468643 | 110093445 |
| Restrictive pulmonary disease | 35.73 | 21.99 | 17 | 27194 | 3242 | 110558846 |
| Skin reaction | 35.04 | 21.99 | 34 | 27177 | 21110 | 110540978 |
| Pain | 34.58 | 21.99 | 120 | 27091 | 954835 | 109607253 |
| Overdose | 33.79 | 21.99 | 8 | 27203 | 233786 | 110328302 |
| Pruritus | 32.79 | 21.99 | 250 | 26961 | 581310 | 109980778 |
| Walking aid user | 31.93 | 21.99 | 35 | 27176 | 25040 | 110537048 |
| Rheumatoid arthritis | 31.84 | 21.99 | 17 | 27194 | 299596 | 110262492 |
| Hypokalaemia | 31.25 | 21.99 | 4 | 27207 | 182444 | 110379644 |
| Fibromyalgia | 31.16 | 21.99 | 3 | 27208 | 170906 | 110391182 |
| Feeling cold | 30.99 | 21.99 | 40 | 27171 | 33947 | 110528141 |
| Hot flush | 30.82 | 21.99 | 57 | 27154 | 65979 | 110496109 |
| Total lung capacity decreased | 30.47 | 21.99 | 20 | 27191 | 7094 | 110554994 |
| Arteriosclerosis coronary artery | 30.16 | 21.99 | 34 | 27177 | 25084 | 110537004 |
| Chronic respiratory failure | 29.97 | 21.99 | 16 | 27195 | 3887 | 110558201 |
| Haemochromatosis | 29.72 | 21.99 | 12 | 27199 | 1545 | 110560543 |
| Cerebrovascular accident | 29.56 | 21.99 | 105 | 27106 | 181179 | 110380909 |
| Lung neoplasm malignant | 29.56 | 21.99 | 39 | 27172 | 33803 | 110528285 |
| Food aversion | 29.01 | 21.99 | 12 | 27199 | 1643 | 110560445 |
| Hypersomnia | 28.73 | 21.99 | 35 | 27176 | 28026 | 110534062 |
| Therapeutic product effect incomplete | 28.05 | 21.99 | 10 | 27201 | 223795 | 110338293 |
| Swelling | 28.04 | 21.99 | 27 | 27184 | 351014 | 110211074 |
| Pulmonary artery dilatation | 27.30 | 21.99 | 9 | 27202 | 651 | 110561437 |
| Malignant neoplasm progression | 27.23 | 21.99 | 5 | 27206 | 174562 | 110387526 |
| Asthma | 26.89 | 21.99 | 14 | 27197 | 250277 | 110311811 |
| Condition aggravated | 26.80 | 21.99 | 92 | 27119 | 734744 | 109827344 |
| Sneezing | 26.62 | 21.99 | 36 | 27175 | 31948 | 110530140 |
| Dry skin | 26.52 | 21.99 | 72 | 27139 | 107581 | 110454507 |
| Pneumomediastinum | 26.17 | 21.99 | 16 | 27195 | 5020 | 110557068 |
| Hypersensitivity | 25.91 | 21.99 | 37 | 27174 | 403961 | 110158127 |
| Type 2 diabetes mellitus | 25.73 | 21.99 | 6 | 27205 | 177226 | 110384862 |
| Hypertension | 25.22 | 21.99 | 55 | 27156 | 510029 | 110052059 |
| Lung diffusion disorder | 25.08 | 21.99 | 7 | 27204 | 287 | 110561801 |
| Stomatitis | 25.02 | 21.99 | 18 | 27193 | 270224 | 110291864 |
| Irritable bowel syndrome | 24.98 | 21.99 | 5 | 27206 | 164210 | 110397878 |
| Upper respiratory tract congestion | 24.96 | 21.99 | 13 | 27198 | 3004 | 110559084 |
| Osteoarthritis | 24.95 | 21.99 | 7 | 27204 | 182616 | 110379472 |
| FEV1/FVC ratio decreased | 24.89 | 21.99 | 7 | 27204 | 295 | 110561793 |
| Inappropriate schedule of product administration | 24.02 | 21.99 | 10 | 27201 | 203627 | 110358461 |
| Insomnia | 23.76 | 21.99 | 161 | 27050 | 360429 | 110201659 |
| Skin discolouration | 23.72 | 21.99 | 43 | 27168 | 49003 | 110513085 |
| Arthralgia | 23.69 | 21.99 | 105 | 27106 | 779527 | 109782561 |
| Hospitalisation | 23.63 | 21.99 | 83 | 27128 | 142410 | 110419678 |
| Irregular breathing | 23.57 | 21.99 | 8 | 27203 | 633 | 110561455 |
| Pharyngeal mass | 23.30 | 21.99 | 7 | 27204 | 373 | 110561715 |
| White blood cell count decreased | 22.96 | 21.99 | 14 | 27197 | 229376 | 110332712 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | L04AX05 | ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS IMMUNOSUPPRESSANTS IMMUNOSUPPRESSANTS Other immunosuppressants |
| FDA CS | M0018236 | Pyridones |
| MeSH PA | D000700 | Analgesics |
| MeSH PA | D000893 | Anti-Inflammatory Agents |
| MeSH PA | D000894 | Anti-Inflammatory Agents, Non-Steroidal |
| MeSH PA | D000970 | Antineoplastic Agents |
| MeSH PA | D002491 | Central Nervous System Agents |
| MeSH PA | D018373 | Peripheral Nervous System Agents |
| MeSH PA | D018501 | Antirheumatic Agents |
| MeSH PA | D018689 | Sensory System Agents |
| MeSH PA | D018712 | Analgesics, Non-Narcotic |
| FDA EPC | N0000191420 | Pyridone |
| CHEBI has role | CHEBI:22587 | antiviral agent |
| CHEBI has role | CHEBI:33281 | antimicrobial agent |
| CHEBI has role | CHEBI:35475 | non-steroidal anti-inflammatory drug |
| CHEBI has role | CHEBI:35481 | non-narcotic analgesic |
| CHEBI has role | CHEBI:35493 | antipyretic |
| CHEBI has role | CHEBI:35554 | cardiovascular drug |
| CHEBI has role | CHEBI:35610 | antineoplastic agent |
| CHEBI has role | CHEBI:35705 | immunosuppressive agent |
| CHEBI has role | CHEBI:76595 | nephroprotective agent |
| CHEBI has role | CHEBI:233423 | antifibrotic agent |
Related Drugs by ATC class:
L04AX Other immunosuppressants 8 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| 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 strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| 267MG | ESBRIET | LEGACY | N022535 | Oct. 15, 2014 | RX | CAPSULE | ORAL | 7767225 | Sept. 22, 2026 | METHOD OF ADMINISTERING PIRFENIDONE CAPSULES TO TREAT A FIBROTIC CONDITION |
| 267MG | ESBRIET | LEGACY | N022535 | Oct. 15, 2014 | RX | CAPSULE | ORAL | 7988994 | Sept. 22, 2026 | METHOD OF ADMINISTERING PIRFENIDONE CAPSULES TO TREAT A FIBROTIC CONDITION |
| 267MG | ESBRIET | LEGACY | N022535 | Oct. 15, 2014 | RX | CAPSULE | ORAL | 8753679 | Sept. 22, 2026 | METHOD OF ADMINISTERING PIRFENIDONE CAPSULES TO TREAT A FIBROTIC CONDITION |
| 267MG | ESBRIET | LEGACY | N022535 | Oct. 15, 2014 | RX | CAPSULE | ORAL | 7696236 | Dec. 18, 2027 | DOSE ESCALATION OVER 14 DAYS FOR TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS |
| 267MG | ESBRIET | LEGACY | N022535 | Oct. 15, 2014 | RX | CAPSULE | ORAL | 7767700 | Dec. 18, 2027 | DOSE ESCALATION OVER 14 DAYS FOR TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS |
| 267MG | ESBRIET | LEGACY | N022535 | Oct. 15, 2014 | RX | CAPSULE | ORAL | 8420674 | Dec. 18, 2027 | DOSE ESCALATION OVER 14 DAYS FOR TREATMENT OF A FIBROSIS CONDITION |
| 267MG | ESBRIET | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | N022535 | Oct. 15, 2014 | RX | CAPSULE | ORAL | 7816383 | Jan. 8, 2030 | METHOD FOR ADMINISTERING PIRFENIDONE TO REDUCE DRUG INTERACTIONS WITH FLUVOXAMINE |
| 267MG | ESBRIET | LEGACY | 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 | LEGACY | N022535 | Oct. 15, 2014 | RX | CAPSULE | ORAL | 8013002 | Jan. 8, 2030 | METHOD FOR ADMINISTERING PIRFENIDONE TO REDUCE DRUG INTERACTIONS WITH FLUVOXAMINE |
| 267MG | ESBRIET | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | N208780 | Jan. 11, 2017 | RX | TABLET | ORAL | 8648098 | Jan. 8, 2030 | DISCONTINUING SMOKING TO AVOID REDUCED PIRFENIDONE EFFICACY AND THEN ADMINISTERING PIRFENIDONE |
| 267MG | ESBRIET | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | N208780 | Jan. 11, 2017 | RX | TABLET | ORAL | 8648098 | Jan. 8, 2030 | DISCONTINUING SMOKING TO AVOID REDUCED PIRFENIDONE EFFICACY AND THEN ADMINISTERING PIRFENIDONE |
| 801MG | ESBRIET | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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 | LEGACY | 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:
| ID | Source |
|---|---|
| 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:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Pirfenidone | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0480-3610 | TABLET, FILM COATED | 267 mg | ORAL | ANDA | 26 sections |
| Pirfenidone | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0480-3611 | TABLET, FILM COATED | 801 mg | ORAL | ANDA | 26 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 | 0781-8086 | TABLET, FILM COATED | 801 mg | ORAL | ANDA | 28 sections |
| PIRFENIDONE | Human Prescription Drug Label | 1 | 0904-7397 | TABLET, FILM COATED | 267 mg | ORAL | ANDA | 26 sections |
| PIRFENIDONE | Human Prescription Drug Label | 1 | 0904-7398 | TABLET, FILM COATED | 801 mg | ORAL | ANDA | 26 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 | 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 Capsule, 267 mg | Human Prescription Drug Label | 1 | 33342-461 | CAPSULE | 267 mg | ORAL | ANDA | 25 sections |
| Pirfenidone | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42291-490 | CAPSULE | 267 mg | ORAL | ANDA | 26 sections |
| Pirfenidone | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42291-491 | TABLET, FILM COATED | 267 mg | ORAL | ANDA | 27 sections |
| Pirfenidone | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42291-492 | TABLET, FILM COATED | 801 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 | 42385-925 | 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 | 42571-335 | TABLET, FILM COATED | 267 mg | ORAL | ANDA | 26 sections |
| Pirfenidone | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42571-336 | TABLET, FILM COATED | 801 mg | ORAL | ANDA | 26 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 |
| ESBRIET | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50242-121 | CAPSULE | 267 mg | ORAL | NDA | 28 sections |
| ESBRIET | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50242-122 | TABLET, COATED | 267 mg | ORAL | NDA | 28 sections |
| ESBRIET | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50242-123 | TABLET, COATED | 801 mg | ORAL | NDA | 28 sections |
| Pirfenidone | HUMAN PRESCRIPTION DRUG LABEL | 1 | 51407-913 | TABLET | 267 mg | ORAL | ANDA | 26 sections |