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

Stem definitionDrug idCAS RN
antineoplastics, daunorubicin derivatives 786 20830-81-3

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • daunorubicin
  • acetyladriamycin
  • cerubidin
  • daunoblastina
  • daunomycine
  • daunorubicine
  • Leukaemomycin C
  • rubidomycin
  • daunorubicin hydrochloride
  • daunorubicin citrate
  • daunorubicin HCl
A very toxic anthracycline aminoglycoside antineoplastic isolated from Streptomyces peucetius and others, used in treatment of LEUKEMIA and other NEOPLASMS.
  • Molecular weight: 527.53
  • Formula: C27H29NO10
  • CLOGP: 0.78
  • LIPINSKI: 2
  • HAC: 11
  • HDO: 5
  • TPSA: 185.84
  • ALOGS: -2.93
  • ROTB: 4
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

None

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Bocci G, Oprea TI, Benet LZ
S (Water solubility) 0.63 mg/mL Bocci G, Oprea TI, Benet LZ
EoM (Fraction excreted unchanged in urine) 0.50 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 2.05 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
Vd (Volume of distribution) 32.05 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 47.57 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.06 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 14.24 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Dec. 19, 1979 FDA
Feb. 24, 2021 PMDA Meiji Seika Pharma Co., Ltd

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
Febrile neutropenia 851.72 25.15 415 10828 118034 63359745
Hypofibrinogenaemia 367.33 25.15 75 11168 1095 63476684
Posterior reversible encephalopathy syndrome 203.94 25.15 86 11157 17259 63460520
Sepsis 202.36 25.15 187 11056 152936 63324843
Neutropenia 156.39 25.15 173 11070 174832 63302947
Hyperbilirubinaemia 152.96 25.15 62 11181 11252 63466527
Bone marrow failure 128.09 25.15 74 11169 29216 63448563
Pneumatosis intestinalis 124.10 25.15 36 11207 2377 63475402
Mucormycosis 117.92 25.15 36 11207 2835 63474944
Colitis 111.80 25.15 82 11161 48446 63429333
Septic shock 111.10 25.15 93 11150 66536 63411243
Neutropenic colitis 111.09 25.15 35 11208 3060 63474719
Cardiotoxicity 109.81 25.15 45 11198 8393 63469386
Thrombocytopenia 107.49 25.15 133 11110 151024 63326755
Human bocavirus infection 103.64 25.15 22 11221 391 63477388
Febrile bone marrow aplasia 101.96 25.15 41 11202 7284 63470495
Clostridium difficile colitis 92.67 25.15 53 11190 20516 63457263
Second primary malignancy 92.00 25.15 39 11204 7914 63469865
Secondary immunodeficiency 90.92 25.15 25 11218 1358 63476421
Human herpesvirus 6 infection 87.97 25.15 29 11214 2928 63474851
Haematotoxicity 85.83 25.15 39 11204 9337 63468442
Central nervous system haemorrhage 84.17 25.15 16 11227 157 63477622
Herpes simplex 84.00 25.15 37 11206 8234 63469545
Mucosal inflammation 83.41 25.15 68 11175 46860 63430919
Enterobacter infection 79.16 25.15 25 11218 2202 63475577
Multiple organ dysfunction syndrome 78.03 25.15 71 11172 56681 63421098
Blood culture positive 74.63 25.15 29 11214 4706 63473073
Venoocclusive liver disease 74.05 25.15 29 11214 4806 63472973
Aplasia 73.99 25.15 28 11215 4231 63473548
Bronchopulmonary aspergillosis 73.03 25.15 34 11209 8601 63469178
Fatigue 71.87 25.15 34 11209 887994 62589785
Arthralgia 68.14 25.15 10 11233 569700 62908079
Aspergillus infection 65.77 25.15 31 11212 8062 63469717
Pancytopenia 65.16 25.15 83 11160 96850 63380929
Gastroenteritis norovirus 64.42 25.15 21 11222 2047 63475732
Pain 61.97 25.15 27 11216 740601 62737178
Venoocclusive disease 60.48 25.15 20 11223 2038 63475741
Left atrial hypertrophy 60.31 25.15 10 11233 40 63477739
Disseminated intravascular coagulation 59.89 25.15 39 11204 19012 63458767
Bacterial infection 59.06 25.15 39 11204 19460 63458319
Ejection fraction decreased 58.90 25.15 41 11202 22291 63455488
Rhinovirus infection 58.39 25.15 24 11219 4505 63473274
Bacteraemia 58.20 25.15 37 11206 17311 63460468
Cerebral venous sinus thrombosis 57.30 25.15 19 11224 1953 63475826
Venous thrombosis 56.56 25.15 24 11219 4878 63472901
Haemophagocytic lymphohistiocytosis 54.99 25.15 30 11213 10597 63467182
Enterococcal infection 54.52 25.15 27 11216 7821 63469958
Pneumonia fungal 54.09 25.15 24 11219 5431 63472348
Tumour lysis syndrome 53.91 25.15 28 11215 8962 63468817
Acute myeloid leukaemia recurrent 52.66 25.15 17 11226 1606 63476173
Angiokeratoma 49.34 25.15 10 11233 140 63477639
Respiratory failure 48.64 25.15 74 11169 101784 63375995
Ankle brachial index decreased 48.15 25.15 9 11234 80 63477699
Pulse waveform abnormal 48.15 25.15 9 11234 80 63477699
Hepatic failure 47.80 25.15 44 11199 35612 63442167
Carotid intima-media thickness increased 47.75 25.15 9 11234 84 63477695
Streptococcal bacteraemia 47.19 25.15 16 11227 1761 63476018
Pyrexia 47.17 25.15 186 11057 470292 63007487
Differentiation syndrome 46.01 25.15 14 11229 1089 63476690
Pneumonia moraxella 45.56 25.15 8 11235 48 63477731
Neutropenic sepsis 45.28 25.15 31 11212 16407 63461372
Cerebral venous thrombosis 44.77 25.15 16 11227 2058 63475721
Neoplasm recurrence 44.58 25.15 17 11226 2621 63475158
Enteritis 44.56 25.15 24 11219 8262 63469517
Alpha haemolytic streptococcal infection 44.10 25.15 14 11229 1253 63476526
Myelosuppression 43.47 25.15 35 11208 23668 63454111
Drug hypersensitivity 43.41 25.15 3 11240 310684 63167095
Acute lymphocytic leukaemia recurrent 43.36 25.15 16 11227 2253 63475526
Leukaemia recurrent 43.35 25.15 14 11229 1324 63476455
Electrocardiogram PR shortened 43.02 25.15 10 11233 273 63477506
Malaise 41.92 25.15 11 11232 415943 63061836
Acute myeloid leukaemia 41.78 25.15 30 11213 17117 63460662
Device related infection 41.76 25.15 34 11209 23358 63454421
Stenotrophomonas infection 41.36 25.15 15 11228 2012 63475767
Pleuroparenchymal fibroelastosis 39.74 25.15 8 11235 108 63477671
Staphylococcal sepsis 39.45 25.15 22 11221 8106 63469673
Pulmonary haemorrhage 39.18 25.15 21 11222 7160 63470619
Pseudomonal sepsis 38.88 25.15 15 11228 2386 63475393
Bone marrow disorder 38.81 25.15 15 11228 2399 63475380
Trichosporon infection 37.49 25.15 9 11234 283 63477496
Abdominal discomfort 37.45 25.15 6 11237 320879 63156900
Blast crisis in myelogenous leukaemia 36.29 25.15 10 11233 547 63477232
Respiratory distress 36.29 25.15 37 11206 33914 63443865
Neuropathy peripheral 36.24 25.15 69 11174 113598 63364181
Otitis externa 35.71 25.15 13 11230 1762 63476017
Alanine aminotransferase increased 35.59 25.15 65 11178 103705 63374074
Neurotoxicity 35.28 25.15 27 11216 16963 63460816
Blood bilirubin increased 35.27 25.15 38 11205 37102 63440677
Hyperglycaemic hyperosmolar nonketotic syndrome 34.72 25.15 11 11232 978 63476801
Chronic myeloid leukaemia recurrent 33.98 25.15 8 11235 231 63477548
Left ventricular dysfunction 33.95 25.15 23 11220 11965 63465814
Acute respiratory distress syndrome 33.41 25.15 30 11213 23504 63454275
Fall 33.19 25.15 14 11229 392320 63085459
Aborted pregnancy 33.12 25.15 6 11237 44 63477735
Cardiac dysfunction 32.35 25.15 13 11230 2302 63475477
Minimal residual disease 32.33 25.15 7 11236 137 63477642
Dyspnoea 32.29 25.15 42 11201 661271 62816508
Tachycardia 31.99 25.15 67 11176 118089 63359690
Ovarian failure 31.69 25.15 11 11232 1299 63476480
Hypotension 31.57 25.15 113 11130 272491 63205288
Hyperglycaemia 31.56 25.15 38 11205 41829 63435950
Hepatocellular injury 31.39 25.15 31 11212 27350 63450429
Pulmonary mucormycosis 31.34 25.15 8 11235 325 63477454
Leukopenia 31.16 25.15 52 11191 77238 63400541
Pseudomonas infection 30.53 25.15 21 11222 11192 63466587
Transient acantholytic dermatosis 30.46 25.15 6 11237 72 63477707
Swelling 30.28 25.15 6 11237 275372 63202407
Pleural effusion 30.22 25.15 57 11186 93153 63384626
Genotoxicity 30.15 25.15 5 11238 20 63477759
Ileus paralytic 29.67 25.15 15 11228 4536 63473243
Cystitis bacterial 28.89 25.15 7 11236 229 63477550
Leukoerythroblastosis 28.80 25.15 7 11236 232 63477547
Geotrichum infection 28.54 25.15 8 11235 466 63477313
Acute myeloid leukaemia refractory 28.51 25.15 6 11237 102 63477677
Breakthrough pain 28.36 25.15 10 11233 1236 63476543
Bacillus infection 27.94 25.15 9 11234 844 63476935
Cholestasis 27.75 25.15 30 11213 29404 63448375
Infusion related reaction 27.73 25.15 5 11238 245516 63232263
Metastases to pancreas 27.32 25.15 7 11236 289 63477490
Dysplasia 27.18 25.15 9 11234 921 63476858
Dizziness 26.95 25.15 22 11221 429903 63047876
Cerebral haemorrhage 26.68 25.15 30 11213 30699 63447080
Premature baby 26.65 25.15 25 11218 20710 63457069
Urinary tract infection 26.63 25.15 7 11236 264677 63213102
Cardiomyopathy 26.12 25.15 23 11220 17561 63460218
Ureaplasma infection 26.04 25.15 8 11235 643 63477136
Pruritus 25.93 25.15 16 11227 361437 63116342
Escherichia bacteraemia 25.91 25.15 13 11230 3870 63473909
Escherichia infection 25.89 25.15 20 11223 12734 63465045
Cardiac failure 25.84 25.15 52 11191 89090 63388689
Cardiogenic shock 25.73 25.15 23 11220 17909 63459870
Cardiac arrest 25.66 25.15 53 11190 92492 63385287
Staphylococcal infection 25.62 25.15 34 11209 41222 63436557

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
Febrile neutropenia 590.64 20.27 458 13022 136391 34807060
Hypofibrinogenaemia 325.26 20.27 84 13396 1602 34941849
Posterior reversible encephalopathy syndrome 230.19 20.27 100 13380 9854 34933597
Bone marrow failure 173.08 20.27 119 13361 29134 34914317
Aspergillus infection 159.82 20.27 83 13397 12171 34931280
Septic shock 157.85 20.27 165 13315 71669 34871782
Neutropenia 149.78 20.27 238 13242 156540 34786911
Acute myeloid leukaemia recurrent 143.25 20.27 47 13433 2123 34941328
Hyperbilirubinaemia 127.58 20.27 80 13400 16763 34926688
Sepsis 126.08 20.27 228 13252 166333 34777118
Myelosuppression 124.96 20.27 83 13397 19182 34924269
Mucormycosis 115.87 20.27 53 13427 5889 34937562
Haematotoxicity 111.14 20.27 57 13423 8137 34935314
Multiple-drug resistance 109.34 20.27 49 13431 5190 34938261
Hypertriglyceridaemia 106.64 20.27 56 13424 8392 34935059
Bronchopulmonary aspergillosis 104.45 20.27 67 13413 14592 34928859
Pneumonia fungal 103.92 20.27 52 13428 7048 34936403
Pancytopenia 94.16 20.27 147 13333 95010 34848441
Fungal infection 85.27 20.27 61 13419 15874 34927577
Leukaemia recurrent 83.04 20.27 29 13451 1586 34941865
Blood fibrinogen decreased 82.63 20.27 27 13453 1203 34942248
Cerebral venous thrombosis 82.23 20.27 24 13456 730 34942721
Hepatotoxicity 81.46 20.27 67 13413 21418 34922033
Thymus hypoplasia 81.44 20.27 21 13459 397 34943054
Lymphoid tissue hypoplasia 81.44 20.27 21 13459 397 34943054
Colitis 77.97 20.27 84 13396 37666 34905785
Disseminated aspergillosis 72.75 20.27 22 13458 758 34942693
Neutropenic colitis 70.73 20.27 31 13449 3113 34940338
Bacteraemia 69.59 20.27 59 13421 19658 34923793
Multiple organ dysfunction syndrome 68.45 20.27 113 13367 76453 34866998
Acute lymphocytic leukaemia recurrent 68.43 20.27 30 13450 3014 34940437
Tumour lysis syndrome 66.34 20.27 54 13426 17005 34926446
Glioma 64.47 20.27 17 13463 352 34943099
Skin toxicity 64.06 20.27 33 13447 4751 34938700
Central nervous system fungal infection 60.55 20.27 16 13464 334 34943117
Venoocclusive disease 60.41 20.27 27 13453 2840 34940611
Fatigue 59.12 20.27 35 13445 370618 34572833
Pyrexia 58.32 20.27 268 13212 332745 34610706
Osteonecrosis 57.62 20.27 47 13433 14843 34928608
Febrile bone marrow aplasia 54.73 20.27 36 13444 8173 34935278
Cerebral venous sinus thrombosis 53.66 20.27 16 13464 525 34942926
Mucosal inflammation 53.34 20.27 70 13410 38552 34904899
Clostridium difficile colitis 51.30 20.27 45 13435 15685 34927766
Death 48.95 20.27 49 13431 398000 34545451
Glioblastoma multiforme 48.76 20.27 16 13464 722 34942729
Differentiation syndrome 45.21 20.27 18 13462 1420 34942031
Blood bilirubin increased 44.71 20.27 64 13416 38232 34905219
Arthralgia 40.87 20.27 8 13472 170033 34773418
Inappropriate antidiuretic hormone secretion 40.62 20.27 36 13444 12717 34930734
Systemic mycosis 40.28 20.27 17 13463 1556 34941895
Brain sarcoma 39.41 20.27 7 13473 17 34943434
Lower respiratory tract infection fungal 39.23 20.27 13 13467 605 34942846
Oesophageal stenosis 38.72 20.27 17 13463 1713 34941738
Device related infection 38.48 20.27 40 13440 17197 34926254
Lymphopenia 38.44 20.27 39 13441 16296 34927155
Candida endophthalmitis 38.41 20.27 9 13471 112 34943339
Neoplasm recurrence 37.47 20.27 18 13462 2231 34941220
Dizziness 37.12 20.27 19 13461 218502 34724949
Haemophagocytic lymphohistiocytosis 36.19 20.27 34 13446 12939 34930512
Aplasia 35.24 20.27 22 13458 4566 34938885
Congenital pneumonia 34.56 20.27 8 13472 94 34943357
Pain 34.46 20.27 18 13462 204657 34738794
Personality change due to a general medical condition 34.42 20.27 7 13473 42 34943409
Leukoencephalopathy 34.37 20.27 21 13459 4194 34939257
Large intestine infection 34.25 20.27 15 13465 1503 34941948
Cytomegalovirus viraemia 34.23 20.27 26 13454 7404 34936047
Product use in unapproved indication 33.03 20.27 110 13370 117389 34826062
Myocardial infarction 32.93 20.27 4 13476 121081 34822370
Infection 32.91 20.27 93 13387 90822 34852629
Acute monocytic leukaemia 32.89 20.27 10 13470 351 34943100
Disseminated intravascular coagulation 32.39 20.27 41 13439 21775 34921676
Candida infection 32.37 20.27 37 13443 17678 34925773
Gallbladder empyema 32.35 20.27 7 13473 59 34943392
Cerebellar tumour 32.04 20.27 7 13473 62 34943389
Meningeal neoplasm 32.04 20.27 7 13473 62 34943389
Respiratory failure 31.73 20.27 103 13377 108469 34834982
Systemic candida 31.51 20.27 19 13461 3707 34939744
Hepatic steatosis 31.30 20.27 37 13443 18325 34925126
Intussusception 30.92 20.27 11 13469 635 34942816
Malaise 30.31 20.27 17 13463 185808 34757643
Escherichia infection 29.75 20.27 25 13455 8220 34935231
Thrombocytopenia 28.87 20.27 128 13352 156119 34787332
Bacterial infection 28.45 20.27 34 13446 17029 34926422
Pseudomonas test positive 28.24 20.27 12 13468 1117 34942334
Stomatitis 28.02 20.27 55 13425 42459 34900992
Hypoxia 27.89 20.27 64 13416 55031 34888420
Neurotoxicity 26.98 20.27 34 13446 17976 34925475
Dyspnoea 25.13 20.27 69 13411 376713 34566738
Asthenia 24.92 20.27 35 13445 245216 34698235
Prothrombin level abnormal 24.82 20.27 6 13474 86 34943365
Overdose 24.77 20.27 3 13477 91056 34852395
Coagulopathy 24.46 20.27 34 13446 19755 34923696
Pancreatitis acute 24.39 20.27 41 13439 28100 34915351
Central nervous system haemorrhage 24.21 20.27 6 13474 96 34943355
Mixed anxiety and depressive disorder 23.81 20.27 6 13474 103 34943348
Hip deformity 23.76 20.27 6 13474 104 34943347
Myocardial oedema 23.55 20.27 7 13473 227 34943224
Non-alcoholic steatohepatitis 23.46 20.27 10 13470 938 34942513
Ileus paralytic 23.34 20.27 19 13461 5978 34937473
Enamel anomaly 22.99 20.27 6 13474 119 34943332
Escherichia sepsis 22.86 20.27 17 13463 4687 34938764
Renal replacement therapy 22.71 20.27 5 13475 46 34943405
Nervous system disorder 22.65 20.27 28 13452 14515 34928936
Second primary malignancy 22.63 20.27 21 13459 7865 34935586
Superior sagittal sinus thrombosis 22.46 20.27 7 13473 267 34943184
Acute myeloid leukaemia 22.00 20.27 31 13449 18239 34925212
Pulmonary mucormycosis 21.86 20.27 9 13471 774 34942677
Enterococcal infection 21.49 20.27 22 13458 9284 34934167
Leukopenia 21.47 20.27 63 13417 62793 34880658
Drug resistance 21.44 20.27 37 13443 25890 34917561
Rash 21.43 20.27 33 13447 222719 34720732
Intracranial tumour haemorrhage 21.08 20.27 7 13473 328 34943123
Graft versus host disease in skin 20.92 20.27 15 13465 3910 34939541
Vascular access complication 20.92 20.27 7 13473 336 34943115
Graft versus host disease 20.89 20.27 23 13457 10546 34932905
Intracranial pressure increased 20.82 20.27 15 13465 3940 34939511
Cytopenia 20.63 20.27 25 13455 12698 34930753

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
Febrile neutropenia 1314.25 20.91 838 23653 230161 79489736
Posterior reversible encephalopathy syndrome 409.43 20.91 187 24304 26094 79693803
Hypofibrinogenaemia 379.58 20.91 94 24397 1908 79717989
Secondary immunodeficiency 348.59 20.91 97 24394 3137 79716760
Bone marrow failure 320.28 20.91 198 24293 50909 79668988
Aspergillus infection 319.51 20.91 143 24348 19018 79700879
Sepsis 294.65 20.91 387 24104 269041 79450856
Neutropenia 285.28 20.91 394 24097 287316 79432581
Bacterial infection 269.49 20.91 149 24342 31131 79688766
Bronchopulmonary aspergillosis 251.03 20.91 127 24364 22167 79697730
Septic shock 246.42 20.91 242 24249 122559 79597338
Clostridium difficile colitis 219.94 20.91 132 24359 32151 79687746
Hyperbilirubinaemia 198.11 20.91 112 24379 24406 79695491
Thymus hypoplasia 196.14 20.91 48 24443 925 79718972
Haematotoxicity 191.21 20.91 94 24397 15425 79704472
Acute myeloid leukaemia recurrent 184.48 20.91 60 24431 3323 79716574
Lymphoid tissue hypoplasia 183.02 20.91 45 24446 885 79719012
Mycobacterium chelonae infection 181.73 20.91 55 24436 2401 79717496
Mucormycosis 176.47 20.91 74 24417 8395 79711502
Neutropenic colitis 168.09 20.91 64 24427 5643 79714254
Colitis 163.06 20.91 153 24338 73154 79646743
Pneumonia fungal 162.73 20.91 76 24415 11134 79708763
Pseudomonal sepsis 159.68 20.91 63 24428 6111 79713786
Human bocavirus infection 156.53 20.91 38 24453 707 79719190
Human herpesvirus 6 infection 150.20 20.91 58 24433 5312 79714585
Myelosuppression 149.50 20.91 113 24378 40183 79679714
Pancytopenia 147.66 20.91 216 24275 165529 79554368
Parainfluenzae virus infection 129.72 20.91 53 24438 5629 79714268
Fatigue 126.84 20.91 64 24427 929663 78790234
Mucosal inflammation 126.15 20.91 135 24356 75445 79644452
Pneumatosis intestinalis 123.65 20.91 53 24438 6344 79713553
Leukaemia recurrent 122.60 20.91 42 24449 2732 79717165
Multiple organ dysfunction syndrome 122.28 20.91 167 24324 120079 79599818
Fungal infection 120.44 20.91 101 24390 41647 79678250
Febrile bone marrow aplasia 120.32 20.91 65 24426 12955 79706942
Pain 119.95 20.91 34 24457 703768 79016129
Bacteraemia 117.24 20.91 90 24401 32734 79687163
Hypertriglyceridaemia 116.06 20.91 63 24428 12677 79707220
Arthralgia 114.86 20.91 19 24472 571784 79148113
Multiple-drug resistance 113.43 20.91 55 24436 8753 79711144
Cytomegalovirus viraemia 112.91 20.91 62 24429 12759 79707138
Thrombocytopenia 110.12 20.91 248 24243 265011 79454886
Acute lymphocytic leukaemia recurrent 107.62 20.91 44 24447 4680 79715217
Tumour lysis syndrome 104.32 20.91 74 24417 23865 79696032
Cystitis bacterial 103.34 20.91 27 24464 683 79719214
Venoocclusive disease 102.16 20.91 42 24449 4531 79715366
Disseminated aspergillosis 100.01 20.91 29 24462 1089 79718808
Second primary malignancy 98.53 20.91 59 24432 14291 79705606
Pyrexia 97.52 20.91 439 24052 678270 79041627
Central nervous system haemorrhage 97.08 20.91 22 24469 299 79719598
Norovirus test positive 95.51 20.91 25 24466 637 79719260
Enterobacter infection 95.50 20.91 40 24451 4522 79715375
Cerebral venous sinus thrombosis 94.71 20.91 33 24458 2258 79717639
Aplasia 92.25 20.91 46 24445 7774 79712123
Disseminated intravascular coagulation 91.77 20.91 81 24410 35761 79684136
Cardiotoxicity 88.42 20.91 52 24439 12187 79707710
Neoplasm recurrence 85.04 20.91 36 24455 4178 79715719
Enteritis 84.97 20.91 54 24437 14529 79705368
Viral infection 84.69 20.91 84 24407 42932 79676965
Differentiation syndrome 84.14 20.91 31 24460 2493 79717404
Rhinovirus infection 82.81 20.91 43 24448 7910 79711987
Malaise 80.90 20.91 25 24466 489844 79230053
Abscess bacterial 80.71 20.91 23 24468 811 79719086
Diffuse alveolar damage 80.16 20.91 33 24458 3571 79716326
Blood fibrinogen decreased 79.87 20.91 28 24463 1951 79717946
Hepatotoxicity 79.16 20.91 88 24403 51264 79668633
Cerebral venous thrombosis 77.93 20.91 30 24461 2723 79717174
Glioma 77.90 20.91 21 24470 601 79719296
Viraemia 76.73 20.91 30 24461 2839 79717058
Haemophagocytic lymphohistiocytosis 73.89 20.91 58 24433 21779 79698118
Device related infection 71.30 20.91 69 24422 34225 79685672
Dizziness 70.44 20.91 37 24454 526404 79193493
Respiratory failure 70.40 20.91 165 24326 180746 79539151
Blood culture positive 66.70 20.91 38 24453 8391 79711506
Oesophageal candidiasis 66.15 20.91 39 24452 9179 79710718
Cytomegalovirus chorioretinitis 60.96 20.91 31 24460 5459 79714438
Dyspnoea 60.40 20.91 107 24384 856918 78862979
Acute myeloid leukaemia 60.21 20.91 60 24431 30825 79689072
Ejection fraction decreased 59.85 20.91 63 24428 34514 79685383
Skin toxicity 59.20 20.91 35 24456 8279 79711618
Blood bilirubin increased 58.42 20.91 86 24405 66146 79653751
Drug hypersensitivity 57.60 20.91 11 24480 298905 79420992
Pulmonary haemorrhage 56.17 20.91 42 24449 14675 79705222
Enterococcal infection 56.04 20.91 43 24448 15617 79704280
Glioblastoma multiforme 55.86 20.91 19 24472 1209 79718688
Pruritus 55.37 20.91 26 24465 394622 79325275
Venoocclusive liver disease 55.03 20.91 38 24453 11733 79708164
Fall 54.60 20.91 42 24449 487587 79232310
Coronavirus infection 54.54 20.91 32 24459 7465 79712432
Left atrial hypertrophy 52.99 20.91 10 24481 50 79719847
Inappropriate antidiuretic hormone secretion 52.93 20.91 52 24439 26261 79693636
Alopecia 52.87 20.91 5 24486 231350 79488547
Ileus paralytic 52.04 20.91 34 24457 9586 79710311
Abdominal discomfort 50.99 20.91 8 24483 250719 79469178
Pancreatitis acute 50.52 20.91 69 24422 49535 79670362
Staphylococcal sepsis 49.57 20.91 39 24452 14687 79705210
Lower respiratory tract infection fungal 49.43 20.91 16 24475 872 79719025
Osteonecrosis 49.14 20.91 54 24437 31041 79688856
Pulmonary mucormycosis 49.00 20.91 17 24474 1148 79718749
Fusarium infection 48.44 20.91 19 24472 1813 79718084
Pseudomonas test positive 48.24 20.91 19 24472 1833 79718064
Systemic mycosis 47.96 20.91 21 24470 2645 79717252
Carotid intima-media thickness increased 47.79 20.91 10 24481 91 79719806
Peripheral swelling 47.73 20.91 12 24479 269605 79450292
Respiratory distress 47.52 20.91 73 24418 58266 79661631
Neurotoxicity 47.16 20.91 54 24437 32464 79687433
Alpha haemolytic streptococcal infection 47.08 20.91 20 24471 2340 79717557
Brain sarcoma 46.99 20.91 8 24483 19 79719878
Escherichia infection 46.67 20.91 41 24450 17976 79701921
Lymphopenia 46.46 20.91 52 24439 30505 79689392
Candida infection 46.45 20.91 58 24433 38156 79681741
Acute respiratory distress syndrome 45.94 20.91 62 24429 44005 79675892
Infusion related reaction 45.36 20.91 8 24483 230229 79489668
Leukopenia 45.00 20.91 106 24385 116407 79603490
Nausea 44.84 20.91 148 24343 957048 78762849
Minimal residual disease 44.68 20.91 13 24478 494 79719403
Hyperglycaemic hyperosmolar nonketotic syndrome 44.24 20.91 19 24472 2284 79717613
Depression 43.89 20.91 7 24484 216783 79503114
Insomnia 43.22 20.91 11 24480 245159 79474738
Ankle brachial index decreased 43.20 20.91 9 24482 80 79719817
Venous thrombosis 43.08 20.91 27 24464 7089 79712808
Pulse waveform abnormal 42.90 20.91 9 24482 83 79719814
Renal replacement therapy 41.93 20.91 10 24481 172 79719725
Weight decreased 41.80 20.91 29 24462 355169 79364728
Pseudomonas infection 41.47 20.91 41 24450 20862 79699035
Central nervous system fungal infection 41.45 20.91 12 24479 448 79719449
Intracardiac thrombus 41.25 20.91 22 24469 4271 79715626
Herpes simplex 40.43 20.91 32 24459 12155 79707742
Geotrichum infection 40.05 20.91 14 24477 967 79718930
Hypoxia 39.94 20.91 94 24397 103149 79616748
Urticaria 39.78 20.91 5 24486 185196 79534701
Swelling 39.62 20.91 9 24482 216702 79503195
Product use in unapproved indication 39.59 20.91 167 24324 250192 79469705
Systemic candida 39.48 20.91 25 24466 6681 79713216
Angiokeratoma 39.30 20.91 10 24481 227 79719670
Leukoencephalopathy 38.02 20.91 26 24465 7903 79711994
Transient acantholytic dermatosis 37.83 20.91 9 24482 153 79719744
Hepatic steatosis 37.68 20.91 52 24439 37686 79682211
Hypersensitivity 37.18 20.91 17 24474 262222 79457675
Candida endophthalmitis 37.09 20.91 9 24482 167 79719730
Encephalitis 37.06 20.91 33 24458 14727 79705170
Musculoskeletal stiffness 36.92 20.91 5 24486 175003 79544894
Muscle spasms 36.85 20.91 5 24486 174725 79545172
Gastrointestinal protozoal infection 36.78 20.91 8 24483 89 79719808
Electrocardiogram PR shortened 36.48 20.91 10 24481 305 79719592
Cerebellar tumour 36.07 20.91 8 24483 98 79719799
Gastroenteritis norovirus 35.84 20.91 18 24473 3088 79716809
Pneumonia moraxella 35.56 20.91 8 24483 105 79719792
Large intestine infection 35.49 20.91 18 24473 3151 79716746
Oesophageal stenosis 35.45 20.91 20 24471 4334 79715563
Acute monocytic leukaemia 35.33 20.91 11 24480 528 79719369
Stenotrophomonas infection 35.31 20.91 19 24472 3754 79716143
Alanine aminotransferase increased 35.26 20.91 120 24371 162450 79557447
Escherichia bacteraemia 35.02 20.91 23 24468 6539 79713358
Overdose 35.00 20.91 7 24484 184199 79535698
Myocardial infarction 34.98 20.91 7 24484 184122 79535775
Bacterial sepsis 34.92 20.91 25 24466 8173 79711724
Neutropenic sepsis 34.37 20.91 42 24449 27022 79692875
Toxic optic neuropathy 34.20 20.91 13 24478 1140 79718757
Rash 33.21 20.91 81 24410 578277 79141620
Pleuroparenchymal fibroelastosis 33.04 20.91 8 24483 147 79719750
Antithrombin III decreased 31.92 20.91 10 24481 490 79719407
Superior sagittal sinus thrombosis 31.58 20.91 12 24479 1051 79718846
T-cell type acute leukaemia 31.38 20.91 8 24483 183 79719714
Left ventricular dysfunction 31.25 20.91 34 24457 19327 79700570
Platelet count decreased 30.87 20.91 130 24361 194534 79525363
Gallbladder empyema 30.76 20.91 7 24484 97 79719800
Ileus 30.61 20.91 39 24452 26172 79693725
Streptococcal bacteraemia 30.54 20.91 17 24474 3589 79716308
Hyperglycaemia 30.48 20.91 67 24424 70268 79649629
Pleural effusion 30.42 20.91 106 24385 145156 79574741
Blast crisis in myelogenous leukaemia 30.13 20.91 11 24480 862 79719035
Intracranial pressure increased 30.10 20.91 23 24468 8299 79711598
Contraindicated product administered 29.90 20.91 6 24485 157532 79562365
Aborted pregnancy 29.82 20.91 6 24485 44 79719853
Contusion 29.66 20.91 5 24486 148771 79571126
Weight increased 29.61 20.91 25 24466 277361 79442536
Blood pressure increased 29.49 20.91 14 24477 211346 79508551
Graft versus host disease in skin 29.32 20.91 20 24471 6053 79713844
Neoplasm progression 29.26 20.91 55 24436 51627 79668270
Coagulopathy 29.24 20.91 45 24446 35961 79683936
Myelopathy 29.11 20.91 18 24473 4615 79715282
Bone marrow disorder 28.97 20.91 16 24475 3327 79716570
Chronic myeloid leukaemia recurrent 27.67 20.91 8 24483 297 79719600
Asthenia 27.56 20.91 74 24417 511615 79208282
Diarrhoea 27.23 20.91 159 24332 880330 78839567
Back pain 27.21 20.91 32 24459 304148 79415749
Pancreatitis 27.13 20.91 63 24428 68512 79651385
Gait disturbance 27.08 20.91 15 24476 207491 79512406
Intussusception 27.00 20.91 11 24480 1159 79718738
Tachycardia 26.86 20.91 117 24374 177651 79542246
Enterococcus test positive 26.67 20.91 13 24478 2091 79717806
Blister 26.21 20.91 3 24488 119473 79600424
Pain in extremity 26.03 20.91 45 24446 364493 79355404
Cardiac dysfunction 25.85 20.91 16 24475 4108 79715789
Staphylococcal infection 25.79 20.91 56 24435 58239 79661658
Escherichia sepsis 25.39 20.91 21 24470 8487 79711410
Genotoxicity 24.93 20.91 5 24486 36 79719861
Personality change due to a general medical condition 24.89 20.91 7 24484 235 79719662
Myalgia 24.84 20.91 13 24478 185628 79534269
Hypoaesthesia 24.83 20.91 12 24479 179340 79540557
Bronchitis 24.74 20.91 5 24486 130639 79589258
Seizure 24.61 20.91 119 24372 188715 79531182
Acute febrile neutrophilic dermatosis 24.22 20.91 15 24476 3857 79716040
Toxicity to various agents 24.20 20.91 59 24432 421481 79298416
Hypoalbuminaemia 23.79 20.91 31 24460 21266 79698631
Condition aggravated 23.70 20.91 77 24414 501047 79218850
Neuropathy peripheral 23.67 20.91 96 24395 141209 79578688
Graft versus host disease 23.57 20.91 26 24465 15000 79704897
Oral herpes 23.26 20.91 35 24456 27419 79692478
Bacillus bacteraemia 23.15 20.91 6 24485 147 79719750
Leukoerythroblastosis 23.14 20.91 7 24484 305 79719592
Wheezing 23.08 20.91 4 24487 116660 79603237
Cytomegalovirus infection reactivation 22.91 20.91 20 24471 8696 79711201
Non-alcoholic steatohepatitis 22.84 20.91 12 24479 2260 79717637
Cerebral haemorrhage 22.83 20.91 53 24438 57620 79662277
Radiation myelopathy 22.57 20.91 4 24487 13 79719884
Urinary tract infection 22.35 20.91 31 24460 274481 79445416
Dehydration 22.31 20.91 26 24465 248161 79471736
Fungal sepsis 22.28 20.91 11 24480 1819 79718078
Shock 21.79 20.91 44 24447 43504 79676393
Escherichia test positive 21.65 20.91 13 24478 3162 79716735
Myocardial oedema 21.51 20.91 7 24484 388 79719509
Klebsiella sepsis 21.36 20.91 13 24478 3239 79716658
Hip deformity 21.29 20.91 6 24485 203 79719694
Pharyngeal abscess 21.15 20.91 8 24483 692 79719205
Klebsiella infection 20.95 20.91 25 24466 15695 79704202
Peripheral motor neuropathy 20.95 20.91 13 24478 3354 79716543

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L01DB02 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
ANTINEOPLASTIC AGENTS
CYTOTOXIC ANTIBIOTICS AND RELATED SUBSTANCES
Anthracyclines and related substances
ATC L01XY01 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
ANTINEOPLASTIC AGENTS
OTHER ANTINEOPLASTIC AGENTS
Combinations of antineoplastic agents
FDA CS M0028312 Anthracyclines
FDA MoA N0000000176 Topoisomerase Inhibitors
FDA EPC N0000175414 Anthracycline Topoisomerase Inhibitor
MeSH PA D000903 Antibiotics, Antineoplastic
MeSH PA D000970 Antineoplastic Agents
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D059005 Topoisomerase II Inhibitors
MeSH PA D059003 Topoisomerase Inhibitors
CHEBI has role CHEBI:35610 antineoplastic agents

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

DiseaseRelationSNOMED_IDDOID
Acute lymphoid leukemia indication 91857003 DOID:9952
Acute myeloid leukemia, disease indication 91861009
Erythroleukemia, FAB M6 indication 93451002
Kaposi's sarcoma indication 109385007
Acute promyelocytic leukemia, FAB M3 indication 110004001
Acute monocytic/monoblastic leukemia indication 413442004
Blast crisis of chronic myeloidleukemia indication 413656006
Nephroblastoma off-label use 302849000 DOID:2154
Neuroblastoma off-label use 432328008 DOID:769
Mycosis contraindication 3218000 DOID:1564
Pericarditis contraindication 3238004 DOID:1787
Ventricular tachycardia contraindication 25569003
Viral disease contraindication 34014006 DOID:934
Hyperuricemia contraindication 35885006 DOID:1920
Conduction disorder of the heart contraindication 44808001
Chronic heart failure contraindication 48447003
Myocarditis contraindication 50920009 DOID:820
Epilepsy contraindication 84757009 DOID:1826
Cardiomyopathy contraindication 85898001 DOID:0050700
Bacterial infectious disease contraindication 87628006
Kidney disease contraindication 90708001 DOID:557
Disease of liver contraindication 235856003 DOID:409
Pregnancy, function contraindication 289908002
Neutropenic disorder contraindication 303011007 DOID:1227
Bone marrow depression contraindication 307762000
Breastfeeding (mother) contraindication 413712001
Granulocytopenic disorder contraindication 417672002
Protozoal Infection contraindication




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 7.85 acidic
pKa2 9.79 acidic
pKa3 11.6 acidic
pKa4 8.6 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
100MG;44MG VYXEOS CELATOR PHARMS N209401 Aug. 3, 2017 RX POWDER INTRAVENOUS 8431806 April 22, 2025 FOR THE TREATMENT OF NEWLY-DIAGNOSED THERAPY-RELATED ACUTE MYELOID LEUKEMIA (T-AML) OR AML WITH MYELODYSPLASIA-RELATED CHANGES (AML-MRC) IN ADULTS AND PEDIATRIC PATIENTS 1 YEAR AND OLDER
100MG;44MG VYXEOS CELATOR PHARMS N209401 Aug. 3, 2017 RX POWDER INTRAVENOUS 7850990 Jan. 23, 2027 FOR THE TREATMENT OF NEWLY-DIAGNOSED THERAPY-RELATED ACUTE MYELOID LEUKEMIA (T-AML) OR AML WITH MYELODYSPLASIA-RELATED CHANGES (AML-MRC) IN ADULTS AND PEDIATRIC PATIENTS 1 YEAR AND OLDER
100MG;44MG VYXEOS CELATOR PHARMS N209401 Aug. 3, 2017 RX POWDER INTRAVENOUS 8022279 Sept. 14, 2027 FOR THE TREATMENT OF NEWLY-DIAGNOSED THERAPY-RELATED ACUTE MYELOID LEUKEMIA (T-AML) OR AML WITH MYELODYSPLASIA-RELATED CHANGES (AML-MRC) IN ADULTS AND PEDIATRIC PATIENTS 1 YEAR AND OLDER
100MG;44MG VYXEOS CELATOR PHARMS N209401 Aug. 3, 2017 RX POWDER INTRAVENOUS 8092828 April 1, 2029 FOR THE TREATMENT OF NEWLY-DIAGNOSED THERAPY-RELATED ACUTE MYELOID LEUKEMIA (T-AML) OR AML WITH MYELODYSPLASIA-RELATED CHANGES (AML-MRC) IN ADULTS AND PEDIATRIC PATIENTS 1 YEAR AND OLDER
100MG;44MG VYXEOS CELATOR PHARMS N209401 Aug. 3, 2017 RX POWDER INTRAVENOUS 10028912 Oct. 15, 2032 METHOD OF ADMINISTERING A RECONSTITUTED LIPOSOMAL COMPOSITION CONTAINING CYTARABINE AND DAUNORUBICIN TO TREAT NEWLY-DIAGNOSED THERAPY-RELATED AML (T-AML) OR AML WITH MYELODYSPLASIA-RELATED CHANGES (AML-MRC) IN PATIENTS 1 YEAR AND OLDER
100MG;44MG VYXEOS CELATOR PHARMS N209401 Aug. 3, 2017 RX POWDER INTRAVENOUS 10028912 Oct. 15, 2032 METHOD OF RECONSTITUTING A LYOPHILIZED LIPOSOMAL COMPOSITION FOR ADMINISTERING CYTARABINE AND DAUNORUBICIN TO TREAT NEWLY-DIAGNOSED THERAPY-RELATED AML (T-AML) OR AML WITH MYELODYSPLASIA-RELATED CHANGES (AML-MRC) IN PATIENTS 1 YEAR AND OLDER
100MG;44MG VYXEOS CELATOR PHARMS N209401 Aug. 3, 2017 RX POWDER INTRAVENOUS 10166184 Oct. 15, 2032 METHOD OF RECONSTITUTING A LYOPHILIZED LIPOSOMAL COMPOSITION FOR ADMINISTERING CYTARABINE AND DAUNORUBICIN TO TREAT NEWLY-DIAGNOSED THERAPY-RELATED AML (T-AML) OR AML WITH MYELODYSPLASIA-RELATED CHANGES (AML-MRC) IN PATIENTS 1 YEAR AND OLDER
100MG;44MG VYXEOS CELATOR PHARMS N209401 Aug. 3, 2017 RX POWDER INTRAVENOUS 10835492 Oct. 15, 2032 METHOD OF ADMINISTERING A RECONSTITUTED LIPOSOMAL COMPOSITION CONTAINING CYTARABINE AND DAUNORUBICIN TO TREAT NEWLY-DIAGNOSED THERAPY-RELATED AML (T-AML) OR AML WITH MYELODYSPLASIA-RELATED CHANGES (AML-MRC) IN PATIENTS 1 YEAR AND OLDER

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
100MG;44MG VYXEOS CELATOR PHARMS N209401 Aug. 3, 2017 RX POWDER INTRAVENOUS March 30, 2024 NEW PATIENT POPULATION
100MG;44MG VYXEOS CELATOR PHARMS N209401 Aug. 3, 2017 RX POWDER INTRAVENOUS Aug. 3, 2024 TREATMENT OF ADULTS WITH NEWLY DIAGNOSED THERAPY-RELATED ACUTE MYELOID LEUKEMIA (T-AML) OR AML WITH MYELODYSPLASIA-RELATED CHANGES (AML-MRC)
100MG;44MG VYXEOS CELATOR PHARMS N209401 Aug. 3, 2017 RX POWDER INTRAVENOUS March 30, 2028 TREATMENT OF NEWLY-DIAGNOSED THERAPY-RELATED ACUTE MYELOID LEUKEMIA (T-AML) OR AML WITH MYELODYSPLASIA-RELATED CHANGES (AML-MRC) IN PEDIATRIC PATIENTS AGES 1 YEAR AND OLDER

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
DNA topoisomerase 2-alpha Enzyme INHIBITOR WOMBAT-PK CHEMBL
Multidrug resistance-associated protein 1 Transporter WOMBAT-PK
ATP-binding cassette sub-family G member 2 Transporter WOMBAT-PK
Multidrug resistance-associated protein 6 Transporter WOMBAT-PK
72 kDa type IV collagenase Enzyme IC50 5.72 CHEMBL
Histone deacetylase 1 Enzyme IC50 7.33 CHEMBL
Histone deacetylase 6 Enzyme IC50 7.70 CHEMBL
Histone deacetylase 8 Enzyme IC50 6.66 CHEMBL
Multidrug resistance protein 1 Transporter WOMBAT-PK
ORF 73 Unclassified AC50 5.63 CHEMBL

External reference:

IDSource
4019704 VUID
N0000147796 NUI
D01264 KEGG_DRUG
23541-50-6 SECONDARY_CAS_RN
371770-68-2 SECONDARY_CAS_RN
1364321 RXNORM
4018061 VANDF
4019704 VANDF
C0011015 UMLSCUI
CHEBI:41977 CHEBI
DM1 PDB_CHEM_ID
CHEMBL178 ChEMBL_ID
CHEMBL1563 ChEMBL_ID
D003630 MESH_DESCRIPTOR_UI
DB00694 DRUGBANK_ID
7063 IUPHAR_LIGAND_ID
2257 INN_ID
ZS7284E0ZP UNII
30323 PUBCHEM_CID
11753 MMSL
4538 MMSL
d00205 MMSL
002662 NDDF
004821 NDDF
108790000 SNOMEDCT_US
35300007 SNOMEDCT_US
372715008 SNOMEDCT_US
65972004 SNOMEDCT_US
CHEMBL1200475 ChEMBL_ID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Daunorubicin Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0143-9550 INJECTION 5 mg INTRAVENOUS NDA 21 sections
Daunorubicin Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0143-9551 INJECTION 5 mg INTRAVENOUS NDA 21 sections
daunorubicin hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0703-5233 INJECTION, SOLUTION 5 mg INTRAVENOUS ANDA 26 sections
Daunorubicin Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 42658-019 INJECTION, SOLUTION 5 mg INTRAVENOUS ANDA 22 sections
Daunorubicin Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 42658-021 INJECTION, SOLUTION 5 mg INTRAVENOUS ANDA 22 sections
Daunorubicin Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 42658-021 INJECTION, SOLUTION 5 mg INTRAVENOUS ANDA 22 sections
VYXEOS HUMAN PRESCRIPTION DRUG LABEL 2 68727-745 INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION 44 mg INTRAVENOUS NDA 28 sections
VYXEOS HUMAN PRESCRIPTION DRUG LABEL 2 68727-745 INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION 44 mg INTRAVENOUS NDA 28 sections