lacosamide Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
4310 175481-36-4

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • ertosamide
  • SPM-927
  • lacosamide
  • erlosamide
  • harkoseride
  • vimpat
a functionalized amino acid, selectively enhances slow inactivation of voltage-gated sodium channels, resulting in stabilization of hyperexcitable neuronal membranes and inhibition of repetitive neuronal firing, indicated for partial-onset seizures
  • Molecular weight: 250.30
  • Formula: C13H18N2O3
  • CLOGP: 0.39
  • LIPINSKI: 0
  • HAC: 5
  • HDO: 2
  • TPSA: 67.43
  • ALOGS: -2.73
  • ROTB: 6

  • Status: ONP

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

Drug dosage:

DoseUnitRoute
0.30 g O
0.30 g P

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 3 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 2 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 40 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 22.83 ┬ÁM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
Vd (Volume of distribution) 0.58 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 0.57 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.85 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 12.30 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Aug. 29, 2008 EMA
Oct. 28, 2008 FDA UCB INC

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Seizure 1926.86 17.34 924 16331 122130 46546677
Status epilepticus 1045.84 17.34 329 16926 13650 46655157
Epilepsy 665.97 17.34 270 16985 23468 46645339
Generalised tonic-clonic seizure 502.04 17.34 230 17025 26892 46641915
Multiple-drug resistance 418.98 17.34 111 17144 2454 46666353
Off label use 410.75 17.34 595 16660 379246 46289561
Overdose 241.32 17.34 239 17016 101740 46567067
Partial seizures 223.30 17.34 80 17175 4930 46663877
Focal dyscognitive seizures 221.28 17.34 69 17186 2759 46666048
Diplopia 173.57 17.34 101 17154 19304 46649503
Drug ineffective 169.31 17.34 590 16665 677248 45991559
Pregnancy 166.17 17.34 111 17144 27026 46641781
Petit mal epilepsy 108.91 17.34 42 17213 3178 46665629
Electrocardiogram QRS complex prolonged 99.98 17.34 46 17209 5403 46663404
Irritability 93.82 17.34 81 17174 28865 46639942
Mitochondrial DNULL mutation 87.57 17.34 20 17235 231 46668576
Aura 85.00 17.34 26 17229 973 46667834
Propofol infusion syndrome 78.00 17.34 23 17232 758 46668049
Drug ineffective for unapproved indication 76.84 17.34 57 17198 16356 46652451
Pain 76.01 17.34 41 17214 476907 46191900
Somnolence 75.85 17.34 174 17081 156347 46512460
Atrioventricular block complete 74.32 17.34 42 17213 7585 46661222
Seizure cluster 72.07 17.34 16 17239 161 46668646
Drug interaction 71.52 17.34 200 17055 202894 46465913
Sudden unexplained death in epilepsy 69.30 17.34 17 17238 272 46668535
Maternal exposure during pregnancy 68.38 17.34 130 17125 102419 46566388
Diarrhoea 68.35 17.34 64 17191 559538 46109269
Maternal exposure before pregnancy 67.42 17.34 33 17222 4448 46664359
Balance disorder 67.37 17.34 100 17155 64421 46604386
Change in seizure presentation 65.23 17.34 16 17239 256 46668551
Arthralgia 64.69 17.34 27 17228 364576 46304231
Myoclonic epilepsy 61.78 17.34 20 17235 903 46667904
Neurotoxicity 60.56 17.34 46 17209 13671 46655136
Bradycardia 59.74 17.34 96 17159 66202 46602605
Gene mutation 58.69 17.34 20 17235 1060 46667747
Dyspnoea 58.30 17.34 63 17192 515485 46153322
Abortion spontaneous 58.03 17.34 76 17179 43570 46625237
Ataxia 57.75 17.34 45 17210 13885 46654922
Electroencephalogram abnormal 57.54 17.34 28 17227 3726 46665081
Premature delivery 54.40 17.34 53 17202 22016 46646791
Atrioventricular block 51.90 17.34 32 17223 6779 46662028
Encephalopathy 51.82 17.34 63 17192 33526 46635281
Drug reaction with eosinophilia and systemic symptoms 51.51 17.34 59 17196 29489 46639318
Electrocardiogram PR prolongation 51.21 17.34 16 17239 643 46668164
No adverse event 50.86 17.34 63 17192 34168 46634639
Angiofibroma 49.61 17.34 11 17244 110 46668697
Blood gases abnormal 47.53 17.34 15 17240 623 46668184
Drug resistance 47.16 17.34 44 17211 17324 46651483
Myoclonus 46.15 17.34 40 17215 14312 46654495
Psychotic disorder 46.06 17.34 49 17206 22572 46646235
Abnormal behaviour 45.34 17.34 47 17208 21011 46647796
Cardiac arrest 43.17 17.34 100 17155 90299 46578508
Unmasking of previously unidentified disease 41.54 17.34 14 17241 717 46668090
Aphasia 41.51 17.34 52 17203 28515 46640292
Lymphangioleiomyomatosis 40.31 17.34 10 17245 168 46668639
Pain in extremity 39.99 17.34 23 17232 258657 46410150
Memory impairment 39.64 17.34 88 17167 77249 46591558
Tonic convulsion 39.46 17.34 15 17240 1091 46667716
Joint swelling 39.27 17.34 7 17248 166066 46502741
Aggression 38.94 17.34 45 17210 22699 46646108
Angiomyolipoma 38.86 17.34 10 17245 196 46668611
Partial seizures with secondary generalisation 38.71 17.34 11 17244 317 46668490
Laryngeal stenosis 38.37 17.34 13 17242 677 46668130
Hyperammonaemic encephalopathy 37.20 17.34 17 17238 1965 46666842
Dizziness 36.73 17.34 233 17022 340181 46328626
Abdominal pain 36.20 17.34 20 17235 230011 46438796
Atonic seizures 35.73 17.34 12 17243 608 46668199
Cognitive disorder 35.40 17.34 55 17200 36828 46631979
Back pain 34.92 17.34 17 17238 210022 46458785
Respiratory acidosis 34.86 17.34 24 17231 6124 46662683
Behaviour disorder 34.24 17.34 16 17239 1945 46666862
Metabolic acidosis 33.34 17.34 55 17200 38725 46630082
Tremor 33.14 17.34 106 17149 115533 46553274
Cough 32.12 17.34 23 17232 230226 46438581
Lipids abnormal 31.14 17.34 9 17246 276 46668531
Sinus bradycardia 30.10 17.34 31 17224 13751 46655056
Hallucination, visual 29.99 17.34 35 17220 17838 46650969
Drug withdrawal convulsions 29.97 17.34 13 17242 1328 46667479
Abortion induced 29.81 17.34 27 17228 10233 46658574
Sinusitis 29.54 17.34 6 17249 129762 46539045
Myalgia 29.50 17.34 5 17250 123083 46545724
Stillbirth 29.16 17.34 22 17233 6469 46662338
Injection site pain 28.90 17.34 3 17252 107149 46561658
Disturbance in attention 28.82 17.34 46 17209 31514 46637293
Simple partial seizures 28.78 17.34 10 17245 562 46668245
Food interaction 28.61 17.34 10 17245 572 46668235
Hyperammonaemia 28.14 17.34 19 17236 4697 46664110
Dehydration 27.93 17.34 12 17243 159528 46509279
Atrioventricular block first degree 27.87 17.34 21 17234 6165 46662642
Anticonvulsant drug level decreased 27.61 17.34 12 17243 1232 46667575
Suicide attempt 27.49 17.34 62 17193 54974 46613833
Sinus node dysfunction 27.33 17.34 18 17237 4271 46664536
Infusion related reaction 26.87 17.34 3 17252 101205 46567602
Intrusive thoughts 26.79 17.34 7 17248 146 46668661
Acute kidney injury 26.35 17.34 29 17226 235826 46432981
Cardiotoxicity 26.32 17.34 21 17234 6701 46662106
Anticonvulsant drug level increased 26.08 17.34 12 17243 1408 46667399
Bronchitis 26.08 17.34 4 17251 105975 46562832
Therapeutic product effective for unapproved indication 26.06 17.34 6 17249 72 46668735
Encephalitis autoimmune 25.46 17.34 11 17244 1113 46667694
Drug hypersensitivity 25.08 17.34 32 17223 243793 46425014
Rhesus incompatibility 25.07 17.34 6 17249 86 46668721
Nystagmus 24.91 17.34 19 17236 5680 46663127
Anaemia 24.86 17.34 35 17220 255744 46413063
Electrocardiogram ST segment elevation 24.75 17.34 16 17239 3679 46665128
Therapeutic product ineffective for unapproved indication 24.66 17.34 7 17248 201 46668606
Frontal lobe epilepsy 24.37 17.34 4 17251 5 46668802
Electrocardiogram repolarisation abnormality 24.21 17.34 11 17244 1254 46667553
Intensive care unit acquired weakness 23.98 17.34 9 17246 632 46668175
Systolic dysfunction 23.81 17.34 11 17244 1303 46667504
Nausea 23.78 17.34 153 17102 687301 45981506
Maternal exposure during breast feeding 23.56 17.34 14 17241 2775 46666032
Musculoskeletal stiffness 23.44 17.34 4 17251 97989 46570818
Nasopharyngitis 23.34 17.34 14 17241 153984 46514823
Suicidal ideation 23.28 17.34 59 17196 56323 46612484
Peripheral swelling 23.08 17.34 15 17240 158056 46510751
Blood lactic acid increased 22.85 17.34 18 17237 5639 46663168
Directional Doppler flow tests abnormal 22.61 17.34 4 17251 10 46668797
Swelling 22.37 17.34 9 17246 124502 46544305
Intentional overdose 21.84 17.34 63 17192 64881 46603926
Febrile infection-related epilepsy syndrome 21.83 17.34 4 17251 13 46668794
Sedation 21.75 17.34 34 17221 22876 46645931
Drug level increased 21.29 17.34 30 17225 18411 46650396
Euthyroid sick syndrome 21.21 17.34 5 17250 67 46668740
Ventricular hypokinesia 20.98 17.34 15 17240 4063 46664744
Sinus arrest 20.93 17.34 11 17244 1720 46667087
Amnesia 20.90 17.34 47 17208 41584 46627223
Dysarthria 20.72 17.34 44 17211 37454 46631353
Lipids 20.29 17.34 4 17251 21 46668786
Head injury 19.92 17.34 34 17221 24602 46644205
Violence-related symptom 19.87 17.34 7 17248 410 46668397
Learning disorder 19.67 17.34 7 17248 422 46668385
QRS axis abnormal 19.66 17.34 9 17246 1044 46667763
Atrioventricular block second degree 19.60 17.34 14 17241 3785 46665022
Tachycardia 18.95 17.34 80 17175 99542 46569265
Chest discomfort 18.90 17.34 5 17250 90264 46578543
Arthritis 18.83 17.34 3 17252 77313 46591494
Ventricular fibrillation 18.44 17.34 22 17233 11474 46657333
Prescribed overdose 18.43 17.34 21 17234 10428 46658379
Arrhythmia 18.24 17.34 40 17215 34801 46634006
Drug level decreased 18.05 17.34 16 17239 5896 46662911
Intensive care unit delirium 17.95 17.34 4 17251 41 46668766
Calcinosis 17.93 17.34 10 17245 1759 46667048
Neonatal seizure 17.77 17.34 6 17249 309 46668498
Malaise 17.67 17.34 63 17192 331169 46337638
Asthma 17.48 17.34 6 17249 91536 46577271
Shock 17.47 17.34 30 17225 21815 46646992
Pneumonia aspiration 17.36 17.34 37 17218 31568 46637239

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 1611.70 17.78 813 12792 97662 29841211
Status epilepticus 652.32 17.78 229 13376 10843 29928030
Generalised tonic-clonic seizure 436.25 17.78 201 13404 19350 29919523
Epilepsy 327.89 17.78 167 13438 20002 29918871
Off label use 298.28 17.78 457 13148 248833 29690040
Partial seizures 292.65 17.78 96 13509 3671 29935202
Multiple-drug resistance 212.61 17.78 71 13534 2870 29936003
Drug ineffective 170.43 17.78 433 13172 339954 29598919
Aggression 145.35 17.78 126 13479 36781 29902092
Focal dyscognitive seizures 141.62 17.78 43 13562 1270 29937603
Sudden unexplained death in epilepsy 135.02 17.78 33 13572 417 29938456
Overdose 106.14 17.78 159 13446 84178 29854695
Somnolence 95.11 17.78 163 13442 96600 29842273
Petit mal epilepsy 81.07 17.78 34 13571 2597 29936276
Partial seizures with secondary generalisation 80.06 17.78 19 13586 210 29938663
Drug withdrawal convulsions 68.22 17.78 24 13581 1135 29937738
Aura 65.20 17.78 17 13588 283 29938590
Foetal exposure during pregnancy 62.00 17.78 80 13525 36791 29902082
Necrosis ischaemic 59.11 17.78 15 13590 223 29938650
Behaviour disorder 57.46 17.78 26 13579 2386 29936487
Cognitive disorder 57.44 17.78 62 13543 23628 29915245
Dyspnoea 55.98 17.78 42 13563 333253 29605620
Ataxia 55.17 17.78 44 13561 11418 29927455
Drug resistance 54.71 17.78 56 13549 20077 29918796
Nystagmus 53.69 17.78 30 13575 4308 29934565
Atrioventricular block complete 52.89 17.78 38 13567 8439 29930434
Seizure cluster 52.12 17.78 12 13593 115 29938758
Hyperammonaemia 49.50 17.78 31 13574 5489 29933384
No adverse event 48.32 17.78 49 13556 17370 29921503
Atrioventricular block second degree 48.04 17.78 25 13580 3115 29935758
Congenital hypoplasia of depressor angularis oris muscle 48.04 17.78 8 13597 8 29938865
Superinfection 46.87 17.78 20 13585 1594 29937279
Maternal exposure during pregnancy 45.82 17.78 26 13579 3845 29935028
Atrioventricular block 43.96 17.78 32 13573 7250 29931623
Brain operation 41.96 17.78 12 13593 286 29938587
Exposure via breast milk 40.82 17.78 18 13587 1554 29937319
Myoclonic epilepsy 40.71 17.78 15 13590 811 29938062
Irritability 40.28 17.78 51 13554 22999 29915874
Mucosal ulceration 39.82 17.78 15 13590 863 29938010
Postictal psychosis 38.13 17.78 9 13596 97 29938776
Intestinal ischaemia 36.48 17.78 28 13577 6869 29932004
Coarctation of the aorta 36.39 17.78 12 13593 465 29938408
Diarrhoea 36.39 17.78 60 13545 334043 29604830
Acoustic stimulation tests abnormal 35.40 17.78 8 13597 70 29938803
Bradycardia 33.03 17.78 84 13521 65442 29873431
Haemoglobin decreased 32.97 17.78 6 13599 114092 29824781
Drug ineffective for unapproved indication 32.74 17.78 32 13573 10848 29928025
Agitation 32.27 17.78 74 13531 53999 29884874
Pain 31.22 17.78 20 13585 172621 29766252
Encephalopathy 31.21 17.78 54 13551 32151 29906722
Premature baby 30.87 17.78 38 13567 16653 29922220
Anomaly of external ear congenital 30.80 17.78 8 13597 131 29938742
Depressive symptom 30.75 17.78 15 13590 1630 29937243
Drug interaction 29.71 17.78 173 13432 199395 29739478
Low birth weight baby 28.54 17.78 23 13582 6053 29932820
Hippocampal sclerosis 28.45 17.78 7 13598 91 29938782
Diplopia 28.16 17.78 33 13572 13739 29925134
Febrile neutropenia 27.98 17.78 7 13598 106686 29832187
Dizziness 27.74 17.78 167 13438 194742 29744131
Atrial septal defect 26.57 17.78 23 13582 6678 29932195
Change in seizure presentation 26.50 17.78 6 13599 53 29938820
Intellectual disability 26.39 17.78 11 13594 827 29938046
Congenital melanocytic naevus 26.09 17.78 5 13600 17 29938856
Glioblastoma 25.80 17.78 12 13593 1173 29937700
Arthralgia 24.17 17.78 16 13589 135775 29803098
Pneumonia 24.16 17.78 75 13530 334231 29604642
Abdominal pain 24.12 17.78 16 13589 135638 29803235
Pneumonia aspiration 23.98 17.78 53 13552 37727 29901146
Acute kidney injury 23.87 17.78 56 13549 273786 29665087
Psychotic disorder 23.41 17.78 38 13567 21477 29917396
Dissociation 23.17 17.78 11 13594 1126 29937747
Systemic inflammatory response syndrome 23.04 17.78 21 13584 6525 29932348
Unmasking of previously unidentified disease 22.78 17.78 9 13596 589 29938284
Speech disorder 22.32 17.78 40 13565 24472 29914401
Anger 21.67 17.78 26 13579 11094 29927779
Memory impairment 21.21 17.78 50 13555 37124 29901749
Brain oedema 20.97 17.78 27 13578 12371 29926502
Gastrointestinal haemorrhage 20.88 17.78 6 13599 83440 29855433
Hyperammonaemic encephalopathy 20.79 17.78 12 13593 1832 29937041
Psychogenic seizure 20.78 17.78 7 13598 290 29938583
Haematuria traumatic 20.23 17.78 6 13599 163 29938710
Abnormal behaviour 19.83 17.78 39 13566 25584 29913289
Renal failure 19.40 17.78 18 13587 128948 29809925
Hyperkinesia 19.36 17.78 12 13593 2086 29936787
Drug reaction with eosinophilia and systemic symptoms 19.25 17.78 41 13564 28447 29910426
Drug level decreased 19.22 17.78 18 13587 5787 29933086
Blood lactic acid increased 19.15 17.78 18 13587 5812 29933061
Bradycardia neonatal 19.09 17.78 9 13596 907 29937966
Bradykinesia 19.05 17.78 14 13591 3216 29935657
Periventricular haemorrhage neonatal 19.02 17.78 4 13601 24 29938849
Suicidal ideation 18.91 17.78 47 13558 36067 29902806
Hypothermia neonatal 18.60 17.78 5 13600 94 29938779
Brain neoplasm 18.59 17.78 13 13592 2764 29936109
Anaemia 18.53 17.78 42 13563 207950 29730923
Congenital aortic atresia 18.49 17.78 4 13601 28 29938845
Chills 18.47 17.78 5 13600 72333 29866540
Product availability issue 18.09 17.78 8 13597 695 29938178
Myoclonus 17.99 17.78 26 13579 13286 29925587
Thoracic vertebral fracture 17.93 17.78 10 13595 1430 29937443

Pharmacologic Action:

SourceCodeDescription
ATC N03AX18 NERVOUS SYSTEM
ANTIEPILEPTICS
ANTIEPILEPTICS
Other antiepileptics
FDA PE N0000008486 Decreased Central Nervous System Disorganized Electrical Activity
FDA EPC N0000175753 Anti-epileptic Agent
MeSH PA D000927 Anticonvulsants
MeSH PA D002317 Cardiovascular Agents
MeSH PA D002491 Central Nervous System Agents
MeSH PA D049990 Membrane Transport Modulators
MeSH PA D026941 Sodium Channel Blockers
MeSH PA D061567 Voltage-Gated Sodium Channel Blockers

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Partial Epilepsy Treatment Adjunct indication
Atrial flutter contraindication 5370000
Suicidal thoughts contraindication 6471006
Complete atrioventricular block contraindication 27885002
Orthostatic hypotension contraindication 28651003
Sick sinus syndrome contraindication 36083008 DOID:13884
Chronic heart failure contraindication 48447003
Atrial fibrillation contraindication 49436004 DOID:0060224
Acute nephropathy contraindication 58574008
Second degree atrioventricular block contraindication 195042002
Disease of liver contraindication 235856003 DOID:409
Suicidal contraindication 267073005
Disorder of coronary artery contraindication 414024009
Myocardial ischemia contraindication 414795007 DOID:3393
Severe Cardiac Disease contraindication
First Degree Atrioventricular Heart Block contraindication

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 12.83 acidic

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
Sodium channel protein type 9 subunit alpha Ion channel BLOCKER IC50 6.74 CHEMBL CHEMBL
Carbonic anhydrase 2 Enzyme Ki 6.48 CHEMBL
Carbonic anhydrase 12 Enzyme Ki 5.43 CHEMBL
Carbonic anhydrase 4 Enzyme Ki 6.28 CHEMBL
Carbonic anhydrase 13 Enzyme Ki 5.92 CHEMBL
Carbonic anhydrase 3 Enzyme Ki 6.43 CHEMBL
Carbonic anhydrase 5A, mitochondrial Enzyme Ki 5.34 CHEMBL
Carbonic anhydrase 14 Enzyme Ki 6.33 CHEMBL
Carbonic anhydrase 7 Enzyme Ki 5.35 CHEMBL
Carbonic anhydrase 9 Enzyme Ki 6.45 CHEMBL
Carbonic anhydrase 1 Enzyme Ki 6.44 CHEMBL
Carbonic anhydrase 5B, mitochondrial Enzyme Ki 6.47 CHEMBL
Carbonic anhydrase 6 Enzyme Ki 6.39 CHEMBL
Dihydropyrimidinase-related protein 2 Unclassified WOMBAT-PK
Sodium channel protein type X alpha subunit Unclassified IC50 4.80 CHEMBL
Sodium channel protein type 3 subunit alpha Ion channel IC50 6.38 CHEMBL
Carbonic anhydrase 15 Enzyme Ki 6.34 CHEMBL
Sodium channel protein type 2 subunit alpha Ion channel BLOCKER IC50 4.52 IUPHAR

External reference:

IDSource
4028103 VUID
N0000179735 NUI
D07299 KEGG_DRUG
4028103 VANDF
C0893761 UMLSCUI
CHEBI:135939 CHEBI
CHEMBL58323 ChEMBL_ID
DB06218 DRUGBANK_ID
D000078334 MESH_DESCRIPTOR_UI
C476828 MESH_SUPPLEMENTAL_RECORD_UI
219078 PUBCHEM_CID
7472 IUPHAR_LIGAND_ID
8094 INN_ID
563KS2PQY5 UNII
623400 RXNORM
158490 MMSL
25914 MMSL
d07349 MMSL
012839 NDDF
441532003 SNOMEDCT_US
441647003 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Vimpat HUMAN PRESCRIPTION DRUG LABEL 1 0131-1810 INJECTION 10 mg INTRAVENOUS NDA 36 sections
Vimpat HUMAN PRESCRIPTION DRUG LABEL 1 0131-2477 TABLET, FILM COATED 50 mg ORAL NDA 36 sections
Vimpat HUMAN PRESCRIPTION DRUG LABEL 1 0131-2478 TABLET, FILM COATED 100 mg ORAL NDA 36 sections
Vimpat HUMAN PRESCRIPTION DRUG LABEL 1 0131-2479 TABLET, FILM COATED 150 mg ORAL NDA 36 sections
Vimpat HUMAN PRESCRIPTION DRUG LABEL 1 0131-2480 TABLET, FILM COATED 200 mg ORAL NDA 36 sections
Vimpat HUMAN PRESCRIPTION DRUG LABEL 1 0131-5410 SOLUTION 10 mg ORAL NDA 36 sections
Vimpat HUMAN PRESCRIPTION DRUG LABEL 1 54868-6077 TABLET, FILM COATED 50 mg ORAL NDA 32 sections
Lacosamide Human Prescription Drug Label 1 63850-0053 TABLET, FILM COATED 50 mg ORAL ANDA 31 sections
Lacosamide Human Prescription Drug Label 1 63850-0054 TABLET, FILM COATED 100 mg ORAL ANDA 31 sections
Lacosamide Human Prescription Drug Label 1 63850-0055 TABLET, FILM COATED 150 mg ORAL ANDA 31 sections
Lacosamide Human Prescription Drug Label 1 63850-0056 TABLET, FILM COATED 200 mg ORAL ANDA 31 sections
Lacosamide HUMAN PRESCRIPTION DRUG LABEL 1 65162-912 SOLUTION 10 mg ORAL ANDA 20 sections
Vimpat HUMAN PRESCRIPTION DRUG LABEL 1 70166-617 SOLUTION 10 mg ORAL NDA 34 sections