vigabatrin 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
gabamimetic agents 2819 68506-86-5

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • vigabatrin
  • (+/-)-4-Amino-5-hexenoic acid
  • sabril
  • vigabatrin hydrochloride
  • vigabatrin HCl
The precise mechanism of vigabatrin's anti-seizure effect is unknown, but it is believed to be the result of its action as an irreversible inhibitor of gamma-aminobutyric acid transaminase (GABA-T), the enzyme responsible for the metabolism of the inhibitory neurotransmitter GABA. This action results in increased levels of GABA in the central nervous system.
  • Molecular weight: 129.16
  • Formula: C6H11NO2
  • CLOGP: -2.22
  • LIPINSKI: 0
  • HAC: 3
  • HDO: 2
  • TPSA: 63.32
  • ALOGS: -0.13
  • ROTB: 4

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
2 g O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 3 Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 60 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 442.42 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 99 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
kinase-safety-class ACVR2A,ACVR2B,ACVRL1,AURKA,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK4,CDK5,CDK9,DDR1,DYRK1B,EGFR,EIF2AK3,EPHB4,ERBB2,GRK2,GSK3B,IKBKB,ITK,JAK2,JAK3,MAP2K6,MAP3K21,MAP3K7,MAPK10,MAPK7,MAPKAPK2,MTOR,NTRK1,NTRK2,PDK1,PDK2,PDK4,PIK3CB,PIM2,PRKCD,PRKDC,SIK2,SIK3,STK33,SYK,TEK,TGFBR1,ZAP70 47
kinase-selectivity-class AXL,BRAF,CDK9,EIF2AK3,EPHB4,GRK2,MAP2K6,MAPK7,STK33,SYK,TEK,TGFBR1 12
pfas-class PFAS structural alert (1 = True, 0 = False) 0

Approvals:

DateAgencyCompanyOrphan
Aug. 21, 2009 FDA LUNDBECK LLC

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
Seizure 2090.68 34.71 690 7067 151939 90468751
Drug withdrawal convulsions 708.74 34.71 121 7636 1379 90619311
Magnetic resonance imaging head abnormal 501.10 34.71 98 7659 2458 90618232
Drug ineffective 334.76 34.71 491 7266 1383807 89236883
Status epilepticus 327.26 34.71 103 7654 18771 90601919
Retinogram abnormal 298.78 34.71 43 7714 135 90620555
Product dose omission issue 297.26 34.71 225 7532 291462 90329228
Multiple-drug resistance 266.23 34.71 72 7685 7704 90612986
Death 261.64 34.71 253 7504 456298 90164392
Drug resistance 239.00 34.71 92 7665 30357 90590333
Irritability 181.46 34.71 79 7678 35583 90585107
Somnolence 175.21 34.71 144 7613 208940 90411750
Infantile spasms 151.65 34.71 25 7732 225 90620465
Visual field defect 140.48 34.71 43 7714 7123 90613567
Brain operation 109.35 34.71 22 7735 637 90620053
Generalised tonic-clonic seizure 108.37 34.71 55 7702 34848 90585842
Aggression 106.77 34.71 50 7707 26618 90594072
Tonic convulsion 98.19 34.71 24 7733 1714 90618976
Respiratory distress 97.11 34.71 53 7704 38893 90581797
Epilepsy 93.53 34.71 68 7689 82138 90538552
Abnormal behaviour 83.15 34.71 40 7717 22588 90598102
Hypotonia 80.66 34.71 32 7725 11394 90609296
Focal dyscognitive seizures 79.61 34.71 23 7734 3121 90617569
Partial seizures 79.29 34.71 28 7729 7232 90613458
Intellectual disability 79.00 34.71 19 7738 1267 90619423
Change in seizure presentation 76.15 34.71 16 7741 576 90620114
Hospitalisation 74.71 34.71 72 7685 128028 90492662
Pneumonia aspiration 60.99 34.71 40 7717 40900 90579790
Optic atrophy 60.72 34.71 16 7741 1545 90619145
Bronchiolitis 60.65 34.71 19 7738 3393 90617297
Respiratory failure 56.99 34.71 60 7697 118358 90502332
Seizure cluster 52.84 34.71 11 7746 378 90620312
Retinal injury 52.59 34.71 11 7746 387 90620303
Temporal lobe epilepsy 51.87 34.71 11 7746 414 90620276
Pain 50.10 34.71 12 7745 996329 89624361
Pneumonia 49.77 34.71 143 7614 637916 89982774
Hypoventilation 48.74 34.71 18 7739 5278 90615412
Infantile spitting up 46.42 34.71 8 7749 96 90620594
Myoclonic epilepsy 46.12 34.71 13 7744 1614 90619076
Crying 45.53 34.71 28 7729 25617 90595073
Neurotoxicity 44.77 34.71 26 7731 21441 90599249
Therapeutic product effective for unapproved indication 44.16 34.71 8 7749 130 90620560
Retinal disorder 44.00 34.71 13 7744 1906 90618784
Coma blister 43.34 34.71 8 7749 145 90620545
Rhinovirus infection 39.65 34.71 16 7741 5947 90614743
Epidural lipomatosis 39.14 34.71 8 7749 251 90620439
Anticonvulsant drug level decreased 38.84 34.71 11 7746 1389 90619301
Nausea 38.33 34.71 24 7733 1110292 89510398
Therapeutic product ineffective for unapproved indication 37.94 34.71 8 7749 293 90620397
Viral infection 37.66 34.71 30 7727 41384 90579306
Blindness 37.24 34.71 25 7732 26543 90594147
Respiratory syncytial virus infection 36.90 34.71 18 7739 10462 90610228
Arthralgia 36.02 34.71 11 7746 778511 89842179
Respiratory syncytial virus bronchiolitis 35.15 34.71 8 7749 419 90620271

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
Seizure 1807.52 37.55 716 7323 119845 42493451
Drug withdrawal convulsions 602.37 37.55 117 7922 1221 42612075
Magnetic resonance imaging head abnormal 518.52 37.55 106 7933 1461 42611835
Product dose omission issue 313.22 37.55 247 7792 154118 42459178
Drug ineffective 295.83 37.55 465 7574 629732 41983564
Status epilepticus 266.93 37.55 103 7936 15475 42597821
Retinogram abnormal 248.21 37.55 40 7999 118 42613178
Visual field defect 207.90 37.55 64 7975 4874 42608422
Multiple-drug resistance 190.85 37.55 66 7973 7256 42606040
Infantile spasms 166.96 37.55 31 8008 247 42613049
Death 124.40 37.55 273 7766 470912 42142384
Somnolence 116.51 37.55 138 7901 140967 42472329
Epilepsy 115.54 37.55 68 7971 26103 42587193
Hospitalisation 108.98 37.55 99 7940 74231 42539065
Brain operation 108.00 37.55 24 8015 499 42612797
Infantile spitting up 96.74 37.55 16 8023 58 42613238
Adverse event 92.88 37.55 57 7982 23583 42589713
Anticonvulsant drug level above therapeutic 85.23 37.55 21 8018 692 42612604
Partial seizures 83.67 37.55 34 8005 5825 42607471
Sudden unexplained death in epilepsy 80.86 37.55 19 8020 510 42612786
Excessive eye blinking 77.17 37.55 19 8020 624 42612672
Irritability 72.13 37.55 52 7987 28076 42585220
Visual impairment 70.23 37.55 61 7978 43052 42570244
Gaze palsy 68.91 37.55 22 8017 1883 42611413
Ophthalmological examination abnormal 68.10 37.55 11 8028 33 42613263
Drug resistance 67.27 37.55 54 7985 34194 42579102
Optic atrophy 64.67 37.55 19 8020 1230 42612066
Tonic convulsion 63.49 37.55 20 8019 1639 42611657
Eye movement disorder 61.49 37.55 26 8013 4919 42608377
Myoclonic epilepsy 59.19 37.55 19 8020 1655 42611641
Aggression 59.18 37.55 56 7983 44107 42569189
Cerebral disorder 58.77 37.55 22 8017 3028 42610268
Crying 58.18 37.55 27 8012 6367 42606929
Hypotonia 56.38 37.55 30 8009 9469 42603827
Respiratory syncytial virus infection 55.30 37.55 27 8012 7125 42606171
Generalised tonic-clonic seizure 54.80 37.55 43 7996 26336 42586960
Respiratory distress 54.08 37.55 52 7987 41768 42571528
Acute kidney injury 51.40 37.55 5 8034 367332 42245964
Abnormal behaviour 50.43 37.55 41 7998 26410 42586886
Posture abnormal 47.90 37.55 18 8021 2503 42610793
Pneumonia aspiration 46.26 37.55 52 7987 50026 42563270
Respiratory disorder 45.87 37.55 36 8003 22049 42591247
Postictal paralysis 44.54 37.55 11 8028 366 42612930
Retinal disorder 44.28 37.55 14 8025 1161 42612135
Product use issue 44.27 37.55 63 7976 76688 42536608
Encephalopathy 43.54 37.55 46 7993 41287 42572009
Atonic seizures 43.46 37.55 11 8028 405 42612891
Pneumonia 43.01 37.55 175 7864 421974 42191322
Rhinovirus infection 42.62 37.55 22 8017 6526 42606770
Intramyelinic oedema 42.39 37.55 6 8033 4 42613292
Astrocytoma, low grade 39.81 37.55 8 8031 100 42613196
Febrile convulsion 37.65 37.55 11 8028 698 42612598

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
Seizure 2188.61 31.17 824 10509 220361 110357605
Magnetic resonance imaging head abnormal 908.25 31.17 175 11158 3360 110574606
Drug withdrawal convulsions 829.45 31.17 153 11180 2296 110575670
Status epilepticus 548.01 31.17 180 11153 31391 110546575
Retinogram abnormal 529.29 31.17 80 11253 306 110577660
Product dose omission issue 453.09 31.17 324 11009 321458 110256508
Death 375.04 31.17 406 10927 698463 109879503
Multiple-drug resistance 340.47 31.17 102 11231 13133 110564833
Drug ineffective 323.54 31.17 563 10770 1519977 109057989
Drug resistance 284.36 31.17 131 11202 56243 110521723
Infantile spasms 243.27 31.17 41 11292 350 110577616
Somnolence 229.16 31.17 211 11122 297238 110280728
Visual field defect 226.42 31.17 70 11263 10002 110567964
Brain operation 160.46 31.17 33 11300 887 110577079
Irritability 159.88 31.17 84 11249 47725 110530241
Partial seizures 146.89 31.17 52 11281 11297 110566669
Epilepsy 131.42 31.17 97 11236 100112 110477854
Respiratory distress 128.88 31.17 83 11250 68791 110509175
Tonic convulsion 120.87 31.17 33 11300 3041 110574925
Generalised tonic-clonic seizure 117.63 31.17 72 11261 54608 110523358
Aggression 114.85 31.17 73 11260 59137 110518829
Hypotonia 106.47 31.17 45 11288 15700 110562266
Sudden unexplained death in epilepsy 100.51 31.17 22 11311 801 110577165
Bronchiolitis 97.90 31.17 32 11301 5461 110572505
Myoclonic epilepsy 97.08 31.17 27 11306 2664 110575302
Optic atrophy 94.19 31.17 26 11307 2495 110575471
Pneumonia aspiration 91.84 31.17 72 11261 81161 110496805
Anticonvulsant drug level above therapeutic 91.15 31.17 22 11311 1240 110576726
Abnormal behaviour 90.65 31.17 54 11279 38985 110538981
Pneumonia 84.68 31.17 238 11095 876476 109701490
Focal dyscognitive seizures 83.32 31.17 26 11307 3823 110574143
Excessive eye blinking 82.56 31.17 22 11311 1848 110576118
Retinal disorder 81.93 31.17 23 11310 2347 110575619
Respiratory failure 74.97 31.17 101 11232 215231 110362735
Seizure cluster 73.10 31.17 17 11316 816 110577150
Gaze palsy 69.52 31.17 22 11311 3385 110574581
Change in seizure presentation 67.81 31.17 16 11317 818 110577148
Recalled product administered 65.81 31.17 17 11316 1265 110576701
Neurotoxicity 64.80 31.17 45 11288 42162 110535804
Respiratory syncytial virus infection 61.71 31.17 30 11303 14454 110563512
Respiratory disorder 61.36 31.17 54 11279 71328 110506638
Encephalopathy 61.20 31.17 57 11276 80998 110496968
Crying 60.92 31.17 36 11297 25592 110552374
Petit mal epilepsy 59.24 31.17 24 11309 7523 110570443
Febrile convulsion 58.35 31.17 15 11318 1095 110576871
Cerebral disorder 58.06 31.17 23 11310 6803 110571163
Pain 55.03 31.17 15 11318 954940 109623026
Rhinovirus infection 55.03 31.17 26 11307 11763 110566203
Intramyelinic oedema 54.14 31.17 7 11326 4 110577962
Viral infection 53.44 31.17 44 11289 53095 110524871
Eye movement disorder 53.37 31.17 24 11309 9704 110568262
Electroencephalogram abnormal 53.20 31.17 21 11312 6152 110571814
Posture abnormal 52.38 31.17 19 11314 4419 110573547
Nausea 51.01 31.17 32 11301 1235658 109342308
Atonic seizures 48.22 31.17 13 11320 1141 110576825
Temporal lobe epilepsy 48.16 31.17 11 11322 487 110577479
Postictal paralysis 45.75 31.17 11 11322 610 110577356
Intellectual disability 45.50 31.17 14 11319 1965 110576001
Arthralgia 45.35 31.17 12 11321 779620 109798346
Anticonvulsant drug level decreased 44.44 31.17 14 11319 2122 110575844
Dyskinesia 44.37 31.17 39 11294 51407 110526559
Ataxia 43.65 31.17 31 11302 30077 110547889
Astrocytoma, low grade 43.26 31.17 8 11325 121 110577845
Infantile spitting up 42.87 31.17 6 11327 11 110577955
Ophthalmological examination abnormal 41.50 31.17 7 11326 60 110577906
Therapeutic product effective for unapproved indication 41.39 31.17 8 11325 155 110577811
Acute kidney injury 40.49 31.17 8 11325 635422 109942544
Pruritus 39.95 31.17 6 11327 581554 109996412
Poor feeding infant 39.64 31.17 8 11325 195 110577771
Hospitalisation 39.48 31.17 60 11273 142433 110435533
Agitation 39.25 31.17 53 11280 112998 110464968
Coma blister 38.58 31.17 8 11325 224 110577742
Strabismus 37.67 31.17 14 11319 3485 110574481
Enterovirus infection 37.01 31.17 13 11320 2757 110575209
Benign cardiac neoplasm 36.65 31.17 6 11327 42 110577924
Therapeutic product ineffective for unapproved indication 36.16 31.17 8 11325 306 110577660
Tuberous sclerosis complex 36.05 31.17 7 11326 139 110577827
Hypoventilation 35.21 31.17 17 11316 8064 110569902
Epileptic encephalopathy 34.76 31.17 9 11324 676 110577290
Product contamination 33.40 31.17 11 11322 1920 110576046
Gingival atrophy 33.15 31.17 6 11327 80 110577886
Lissencephaly 32.75 31.17 4 11329 0 110577966
Lethargy 32.68 31.17 44 11289 93532 110484434
Dysmetria 32.60 31.17 10 11323 1389 110576577
Chorea 31.41 31.17 12 11321 3223 110574743

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC N03AG04 NERVOUS SYSTEM
ANTIEPILEPTICS
ANTIEPILEPTICS
Fatty acid derivatives
FDA EPC N0000175753 Anti-epileptic Agent
MeSH PA D000927 Anticonvulsants
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D018682 GABA Agents
CHEBI has role CHEBI:35623 anticonvulsant
CHEBI has role CHEBI:53784 antispasmodic drug
CHEBI has role CHEBI:63674 EC 2.6.1.19 (4-aminobutyrate—2-oxoglutarate transaminase) inhibitor
CHEBI has role CHEBI:74518 anti-obesity agent

Related Drugs by ATC class:

N03AG Fatty acid derivatives 5 drugs

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

DiseaseRelationSNOMED_IDDOID
West syndrome indication 28055006
Epilepsy characterized by intractable complex partial seizures indication 442481002
Suicidal thoughts contraindication 6471006
Weight gain finding contraindication 8943002
Visual field defect contraindication 12184005
Reduced visual acuity contraindication 13164000
Mood swings contraindication 18963009
Kidney disease contraindication 90708001 DOID:557
Edema contraindication 267038008
Anemia contraindication 271737000 DOID:2355
Pregnancy, function contraindication 289908002
Peripheral nerve disease contraindication 302226006
Breastfeeding (mother) contraindication 413712001




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 3.94 acidic
pKa2 10.16 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
4-aminobutyrate aminotransferase, mitochondrial Enzyme INHIBITOR CHEMBL CHEMBL
Gamma-amino-N-butyrate transaminase Enzyme IC50 4.38 CHEMBL
4-aminobutyrate aminotransferase, mitochondrial Enzyme IC50 4.40 CHEMBL

External reference:

IDSource
4025280 VUID
N0000171807 NUI
D00535 KEGG_DRUG
4025280 VANDF
C0048044 UMLSCUI
CHEBI:63638 CHEBI
CHEMBL89598 ChEMBL_ID
5665 PUBCHEM_CID
DB01080 DRUGBANK_ID
D020888 MESH_DESCRIPTOR_UI
5581 INN_ID
4821 IUPHAR_LIGAND_ID
GR120KRT6K UNII
14851 RXNORM
15507 MMSL
36115 MMSL
52922 MMSL
d04669 MMSL
003774 NDDF
310283001 SNOMEDCT_US
322976008 SNOMEDCT_US
GR120KRT6K INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Vigabatrin HUMAN PRESCRIPTION DRUG LABEL 1 0054-0652 TABLET 500 mg ORAL ANDA 33 sections
VIGADRONE HUMAN PRESCRIPTION DRUG LABEL 1 0245-0556 POWDER, FOR SOLUTION 50 mg ORAL ANDA 34 sections
VIGADRONE HUMAN PRESCRIPTION DRUG LABEL 1 0245-6001 TABLET 500 mg ORAL ANDA 36 sections
Vigabatrin HUMAN PRESCRIPTION DRUG LABEL 1 0591-3851 TABLET, FILM COATED 500 mg ORAL ANDA 28 sections
vigabatrin for oral solution HUMAN PRESCRIPTION DRUG LABEL 1 31722-009 POWDER, FOR SOLUTION 50 mg ORAL ANDA 35 sections
Vigabatrin Human Prescription Drug Label 1 42799-950 TABLET 500 mg ORAL ANDA 30 sections
Vigabatrin HUMAN PRESCRIPTION DRUG LABEL 1 43598-651 TABLET, FILM COATED 500 mg ORAL ANDA 32 sections
Vigabatrin HUMAN PRESCRIPTION DRUG LABEL 1 43598-697 POWDER, FOR SOLUTION 50 mg ORAL ANDA 30 sections
VIGABATRIN HUMAN PRESCRIPTION DRUG LABEL 1 49884-358 POWDER, FOR SOLUTION 50 mg ORAL ANDA 31 sections
Vigabatrin Human Prescription Drug Label 1 59651-366 POWDER, FOR SOLUTION 500 mg ORAL ANDA 32 sections
Vigabatrin Human Prescription Drug Label 1 59651-367 TABLET 500 mg ORAL ANDA 31 sections
Vigabatrin HUMAN PRESCRIPTION DRUG LABEL 1 60219-1425 FOR SOLUTION 500 mg ORAL ANDA 29 sections
SABRIL HUMAN PRESCRIPTION DRUG LABEL 1 67386-111 TABLET, FILM COATED 500 mg ORAL NDA 31 sections
SABRIL HUMAN PRESCRIPTION DRUG LABEL 1 67386-111 TABLET, FILM COATED 500 mg ORAL NDA 31 sections
SABRIL HUMAN PRESCRIPTION DRUG LABEL 1 67386-211 POWDER, FOR SOLUTION 50 mg ORAL NDA 32 sections
SABRIL HUMAN PRESCRIPTION DRUG LABEL 1 67386-211 POWDER, FOR SOLUTION 50 mg ORAL NDA 32 sections
VIGABATRIN Human Prescription Drug Label 1 67877-674 POWDER, FOR SOLUTION 50 mg ORAL ANDA 30 sections
Vigabatrin HUMAN PRESCRIPTION DRUG LABEL 1 68180-521 POWDER, FOR SOLUTION 500 mg ORAL ANDA 31 sections
VIGABATRIN HUMAN PRESCRIPTION DRUG LABEL 1 69097-964 POWDER, FOR SOLUTION 500 mg ORAL ANDA 31 sections
Vigabatrin HUMAN PRESCRIPTION DRUG LABEL 1 69238-1424 TABLET 500 mg ORAL ANDA 28 sections
Vigabatrin HUMAN PRESCRIPTION DRUG LABEL 1 69238-1425 FOR SOLUTION 500 mg ORAL ANDA 29 sections
VIGABATRIN HUMAN PRESCRIPTION DRUG LABEL 1 70377-089 POWDER, FOR SOLUTION 500 mg ORAL ANDA 31 sections
vigabatrin HUMAN PRESCRIPTION DRUG LABEL 1 70710-1287 TABLET, FILM COATED 500 mg ORAL ANDA 30 sections
vigabatrin HUMAN PRESCRIPTION DRUG LABEL 1 70710-1494 POWDER, FOR SOLUTION 500 mg ORAL ANDA 31 sections
vigabatrin HUMAN PRESCRIPTION DRUG LABEL 1 70771-1654 TABLET, FILM COATED 500 mg ORAL ANDA 30 sections
vigabatrin HUMAN PRESCRIPTION DRUG LABEL 1 70771-1654 TABLET, FILM COATED 500 mg ORAL ANDA 30 sections
vigabatrin HUMAN PRESCRIPTION DRUG LABEL 1 70771-1742 POWDER, FOR SOLUTION 500 mg ORAL ANDA 31 sections
vigabatrin HUMAN PRESCRIPTION DRUG LABEL 1 70771-1742 POWDER, FOR SOLUTION 500 mg ORAL ANDA 31 sections
Vigabatrin Human Prescription Drug Label 1 72205-093 FOR SOLUTION 50 mg ORAL ANDA 29 sections
vigabatrin HUMAN PRESCRIPTION DRUG LABEL 1 80005-167 TABLET, FILM COATED 500 mg ORAL ANDA 31 sections