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 2043.84 44.42 510 2148 23956 2331471
Status epilepticus 1014.40 44.42 193 2465 2285 2353142
Off label use 690.95 44.42 295 2363 73303 2282124
Generalised tonic-clonic seizure 592.00 44.42 142 2516 5230 2350197
Epilepsy 591.44 44.42 138 2520 4501 2350926
Overdose 423.72 44.42 146 2512 19761 2335666
Drug ineffective 419.07 44.42 233 2425 101391 2254036
Pregnancy 355.81 44.42 103 2555 7846 2347581
Partial seizures 232.17 44.42 48 2610 864 2354563
Dizziness 208.65 44.42 123 2535 58542 2296885
Diplopia 191.29 44.42 53 2605 3412 2352015
Somnolence 178.00 44.42 82 2576 23403 2332024
Focal dyscognitive seizures 175.64 44.42 35 2623 518 2354909
Maternal exposure during pregnancy 165.12 44.42 68 2590 14795 2340632
Multiple-drug resistance 164.10 44.42 29 2629 212 2355215
Bradycardia 154.20 44.42 58 2600 9923 2345504
Abortion spontaneous 134.11 44.42 57 2601 13388 2342039
Petit mal epilepsy 131.92 44.42 29 2629 704 2354723
Tremor 131.42 44.42 64 2594 20597 2334830
Cardiac arrest 128.36 44.42 57 2601 14873 2340554
Drug reaction with eosinophilia and systemic symptoms 126.53 44.42 43 2615 5475 2349952
Depression 123.75 44.42 68 2590 28064 2327363
Irritability 120.11 44.42 43 2615 6384 2349043
Premature delivery 114.61 44.42 35 2623 3165 2352262
Myoclonus 109.95 44.42 32 2626 2451 2352976
Exposure during pregnancy 102.75 44.42 58 2600 25161 2330266
Balance disorder 102.71 44.42 43 2615 9704 2345723
Change in seizure presentation 101.88 44.42 15 2643 25 2355402
Completed suicide 101.20 44.42 54 2604 20980 2334447
Fall 98.41 44.42 71 2587 47028 2308399
Psychotic disorder 97.66 44.42 34 2624 4645 2350782
Vomiting 95.89 44.42 83 2575 71519 2283908
Tachycardia 95.82 44.42 48 2610 16361 2339066
Coma 92.22 44.42 39 2619 9017 2346410
Aura 90.75 44.42 18 2640 259 2355168
Intentional overdose 90.14 44.42 41 2617 11280 2344147
Electrocardiogram QRS complex prolonged 89.97 44.42 23 2635 1079 2354348
Respiratory acidosis 86.38 44.42 21 2637 800 2354627
Confusional state 85.87 44.42 51 2607 24293 2331134
Anxiety 84.46 44.42 54 2604 29305 2326122
Aphasia 80.96 44.42 30 2628 4898 2350529
Mitochondrial DNULL mutation 80.70 44.42 11 2647 6 2355421
Atrioventricular block complete 79.65 44.42 22 2636 1392 2354035
Encephalopathy 79.49 44.42 29 2629 4532 2350895
Laryngeal stenosis 77.26 44.42 13 2645 68 2355359
Abnormal behaviour 74.62 44.42 28 2630 4732 2350695
Gait disturbance 73.71 44.42 45 2613 22500 2332927
Atrioventricular block 73.48 44.42 20 2638 1197 2354230
Sudden unexplained death in epilepsy 73.41 44.42 13 2645 96 2355331
Disturbance in attention 73.27 44.42 29 2629 5656 2349771
Memory impairment 73.04 44.42 37 2621 12886 2342541
Propofol infusion syndrome 72.83 44.42 13 2645 101 2355326
Drug interaction 72.55 44.42 49 2609 29114 2326313
Vertigo 71.58 44.42 33 2625 9351 2346076
Fatigue 71.04 44.42 76 2582 84797 2270630
Loss of consciousness 70.56 44.42 41 2617 18726 2336701
Dysarthria 70.38 44.42 29 2629 6273 2349154
Amnesia 69.73 44.42 30 2628 7223 2348204
Rash 69.57 44.42 64 2594 59494 2295933
Weight increased 66.46 44.42 42 2616 22295 2333132
Electrocardiogram PR prolongation 63.63 44.42 12 2646 130 2355297
Drug ineffective for unapproved indication 63.59 44.42 22 2636 2944 2352483
Toxicity to various agents 62.89 44.42 47 2611 32707 2322720
Headache 60.44 44.42 68 2590 80111 2275316
Gamma-glutamyltransferase increased 60.09 44.42 25 2633 5537 2349890
Suicide attempt 59.96 44.42 31 2627 11251 2344176
Partial seizures with secondary generalisation 56.56 44.42 10 2648 73 2355354
Metabolic acidosis 54.99 44.42 24 2634 5974 2349453
Drug resistance 54.46 44.42 19 2639 2605 2352822
Abortion induced 53.07 44.42 20 2638 3416 2352011
Condition aggravated 52.87 44.42 42 2616 31937 2323490
Ataxia 51.55 44.42 18 2640 2474 2352953
Simple partial seizures 51.13 44.42 10 2648 133 2355294
Cognitive disorder 50.86 44.42 22 2636 5359 2350068
Caesarean section 49.73 44.42 20 2638 4061 2351366
Intentional self-injury 49.51 44.42 20 2638 4107 2351320
Gene mutation 48.73 44.42 10 2648 172 2355255
Stillbirth 48.33 44.42 15 2643 1426 2354001
Ventricular tachycardia 48.22 44.42 18 2640 2993 2352434
Lipids abnormal 48.11 44.42 9 2649 93 2355334
Seizure cluster 47.84 44.42 8 2650 40 2355387
Electroencephalogram abnormal 47.17 44.42 13 2645 814 2354613
Hyponatraemia 47.12 44.42 28 2630 13297 2342130
Nausea 46.68 44.42 71 2587 112118 2243309
Head injury 46.51 44.42 19 2639 4015 2351412
Suicidal ideation 46.40 44.42 26 2632 11061 2344366
Myoclonic epilepsy 46.05 44.42 10 2648 228 2355199
Ventricular fibrillation 45.91 44.42 16 2642 2185 2353242
Arrhythmia 45.32 44.42 21 2637 6007 2349420
Atrioventricular block second degree 44.97 44.42 12 2646 665 2354762
Death 44.87 44.42 59 2599 81409 2274018

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 1751.05 38.75 463 1751 19978 1724589
Status epilepticus 649.09 38.75 136 2078 1910 1742657
Off label use 586.13 38.75 239 1975 38332 1706235
Generalised tonic-clonic seizure 516.06 38.75 128 2086 3918 1740649
Epilepsy 385.00 38.75 101 2113 3858 1740709
Drug ineffective 270.26 38.75 167 2047 63634 1680933
Overdose 238.84 38.75 100 2114 16601 1727966
Partial seizures 228.86 38.75 48 2166 663 1743904
Foetal exposure during pregnancy 154.20 38.75 56 2158 6303 1738264
Focal dyscognitive seizures 151.82 38.75 30 2184 300 1744267
Aggression 151.48 38.75 59 2155 8056 1736511
Sudden unexplained death in epilepsy 150.85 38.75 26 2188 110 1744457
Somnolence 142.65 38.75 70 2144 16669 1727898
Dizziness 136.75 38.75 87 2127 34274 1710293
Bradycardia 107.72 38.75 50 2164 10484 1734083
Fall 95.99 38.75 64 2150 27150 1717417
Toxicity to various agents 87.33 38.75 62 2152 29079 1715488
Multiple-drug resistance 83.00 38.75 18 2196 292 1744275
Atrioventricular block 82.12 38.75 24 2190 1347 1743220
Agitation 81.63 38.75 42 2172 10984 1733583
Drug resistance 80.23 38.75 29 2185 3201 1741366
Cardiac arrest 77.51 38.75 46 2168 15884 1728683
Atrioventricular block complete 76.13 38.75 23 2191 1448 1743119
Ataxia 73.26 38.75 25 2189 2328 1742239
Premature baby 71.51 38.75 26 2188 2916 1741651
Maternal exposure during pregnancy 67.91 38.75 18 2196 702 1743865
Encephalopathy 67.77 38.75 28 2186 4424 1740143
Confusional state 65.32 38.75 46 2168 21232 1723335
Atrioventricular block second degree 65.32 38.75 17 2197 617 1743950
Atrial septal defect 65.00 38.75 20 2194 1338 1743229
Petit mal epilepsy 62.26 38.75 16 2198 552 1744015
Vomiting 62.26 38.75 57 2157 38258 1706309
Aura 61.72 38.75 12 2202 109 1744458
Congenital hypoplasia of depressor angularis oris muscle 59.61 38.75 8 2206 0 1744567
Hepatocellular injury 58.40 38.75 23 2191 3208 1741359
Diplopia 56.13 38.75 21 2193 2549 1742018
Cognitive disorder 55.14 38.75 24 2190 4306 1740261
Gait disturbance 54.91 38.75 34 2180 12636 1731931
Suicide attempt 54.23 38.75 28 2186 7353 1737214
Balance disorder 51.38 38.75 25 2189 5787 1738780
Acoustic stimulation tests abnormal 49.31 38.75 8 2206 21 1744546
Syncope 49.01 38.75 33 2181 14136 1730431
Cholestasis 48.91 38.75 21 2193 3644 1740923
Partial seizures with secondary generalisation 48.88 38.75 9 2205 59 1744508
Suicidal ideation 47.74 38.75 27 2187 8491 1736076
Atrial fibrillation 47.08 38.75 33 2181 15078 1729489
Unmasking of previously unidentified disease 46.56 38.75 9 2205 79 1744488
Low birth weight baby 46.44 38.75 14 2200 873 1743694
Depression 46.43 38.75 34 2180 16635 1727932
Delirium 46.34 38.75 24 2190 6338 1738229
Head injury 45.93 38.75 19 2195 3005 1741562
Inappropriate schedule of product administration 45.50 38.75 25 2189 7434 1737133
Loss of consciousness 45.22 38.75 32 2182 14843 1729724
Tremor 44.01 38.75 30 2184 13101 1731466
Drug ineffective for unapproved indication 43.81 38.75 16 2198 1813 1742754
Abnormal behaviour 43.55 38.75 23 2191 6319 1738248
Hippocampal sclerosis 43.54 38.75 7 2207 17 1744550
Amnesia 43.11 38.75 21 2193 4870 1739697
Psychotic disorder 42.45 38.75 21 2193 5035 1739532
Drug interaction 42.24 38.75 40 2174 27918 1716649
Exposure via breast milk 41.76 38.75 10 2204 256 1744311
Pneumonia aspiration 41.64 38.75 21 2193 5245 1739322
Anomaly of external ear congenital 41.51 38.75 8 2206 69 1744498
Coarctation of the aorta 41.48 38.75 9 2205 146 1744421
Condition aggravated 41.32 38.75 35 2179 21115 1723452
Postictal psychosis 41.31 38.75 7 2207 26 1744541
Mydriasis 40.93 38.75 14 2200 1310 1743257
Hyperammonaemia 39.68 38.75 13 2201 1065 1743502

Pharmacologic Action:

SourceCodeDescription
ATC N03AX18 NERVOUS SYSTEM
ANTIEPILEPTICS
ANTIEPILEPTICS
Other antiepileptics
FDA EPC N0000175753 Anti-epileptic Agent
FDA PE N0000008486 Decreased Central Nervous System Disorganized Electrical Activity
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)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
100MG VIMPAT UCB INC N022253 Oct. 28, 2008 RX TABLET ORAL RE38551 March 17, 2022 METHOD OF TREATING, AS INITIAL LOADING DOSE FOR MONOTHERAPY OR ADJUNCTIVE THERAPY, PARTIAL ONSET-SEIZURES IN A PATIENT WITH EPILEPSY AGED 17 YEARS OR OLDER
100MG VIMPAT UCB INC N022253 Oct. 28, 2008 RX TABLET ORAL RE38551 March 17, 2022 METHOD OF TREATING PARTIAL ONSET SEIZURES IN PATIENTS 4 YEARS OF AGE AND OLDER
150MG VIMPAT UCB INC N022253 Oct. 28, 2008 RX TABLET ORAL RE38551 March 17, 2022 METHOD OF TREATING, AS INITIAL LOADING DOSE FOR MONOTHERAPY OR ADJUNCTIVE THERAPY, PARTIAL ONSET-SEIZURES IN A PATIENT WITH EPILEPSY AGED 17 YEARS OR OLDER
150MG VIMPAT UCB INC N022253 Oct. 28, 2008 RX TABLET ORAL RE38551 March 17, 2022 METHOD OF TREATING PARTIAL ONSET SEIZURES IN PATIENTS 4 YEARS OF AGE AND OLDER
200MG VIMPAT UCB INC N022253 Oct. 28, 2008 RX TABLET ORAL RE38551 March 17, 2022 METHOD OF TREATING, AS INITIAL LOADING DOSE FOR MONOTHERAPY OR ADJUNCTIVE THERAPY, PARTIAL ONSET-SEIZURES IN A PATIENT WITH EPILEPSY AGED 17 YEARS OR OLDER
200MG VIMPAT UCB INC N022253 Oct. 28, 2008 RX TABLET ORAL RE38551 March 17, 2022 METHOD OF TREATING PARTIAL ONSET SEIZURES IN PATIENTS 4 YEARS OF AGE AND OLDER
50MG VIMPAT UCB INC N022253 Oct. 28, 2008 RX TABLET ORAL RE38551 March 17, 2022 METHOD OF TREATING, AS INITIAL LOADING DOSE FOR MONOTHERAPY OR ADJUNCTIVE THERAPY, PARTIAL ONSET-SEIZURES IN A PATIENT WITH EPILEPSY AGED 17 YEARS OR OLDER
50MG VIMPAT UCB INC N022253 Oct. 28, 2008 RX TABLET ORAL RE38551 March 17, 2022 METHOD OF TREATING PARTIAL ONSET SEIZURES IN PATIENTS 4 YEARS OF AGE AND OLDER
200MG/20ML (10MG/ML) VIMPAT UCB INC N022254 Oct. 28, 2008 RX SOLUTION INTRAVENOUS RE38551 March 17, 2022 METHOD OF TREATING, AS INITIAL LOADING DOSE FOR MONOTHERAPY OR ADJUNCTIVE THERAPY, PARTIAL ONSET-SEIZURES IN A PATIENT WITH EPILEPSY AGED 17 YEARS OR OLDER WHEN ORAL ADMINISTRATION IS TEMPORARILY NOT FEASIBLE
200MG/20ML (10MG/ML) VIMPAT UCB INC N022254 Oct. 28, 2008 RX SOLUTION INTRAVENOUS RE38551 March 17, 2022 METHOD OF TREATING, AS MONOTHERAPY OR ADJUNCTIVE THERAPY, PARTIAL-ONSET SEIZURES IN A PATIENT WITH EPILEPSY AGED 17 YEARS AND OLDER WHEN ORAL ADMINISTRATION IS TEMPORARILY NOT FEASIBLE
10MG/ML VIMPAT UCB INC N022255 April 20, 2010 RX SOLUTION ORAL RE38551 March 17, 2022 METHOD OF TREATING, AS INITIAL LOADING DOSE FOR MONOTHERAPY OR ADJUNCTIVE THERAPY, PARTIAL ONSET-SEIZURES IN A PATIENT WITH EPILEPSY AGED 17 YEARS OR OLDER
10MG/ML VIMPAT UCB INC N022255 April 20, 2010 RX SOLUTION ORAL RE38551 March 17, 2022 METHOD OF TREATING PARTIAL ONSET SEIZURES IN PATIENTS 4 YEARS OF AGE AND OLDER

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
100MG VIMPAT UCB INC N022253 Oct. 28, 2008 RX TABLET ORAL Nov. 3, 2020 NEW PATIENT POPULATION
150MG VIMPAT UCB INC N022253 Oct. 28, 2008 RX TABLET ORAL Nov. 3, 2020 NEW PATIENT POPULATION
200MG VIMPAT UCB INC N022253 Oct. 28, 2008 RX TABLET ORAL Nov. 3, 2020 NEW PATIENT POPULATION
50MG VIMPAT UCB INC N022253 Oct. 28, 2008 RX TABLET ORAL Nov. 3, 2020 NEW PATIENT POPULATION
200MG/20ML (10MG/ML) VIMPAT UCB INC N022254 Oct. 28, 2008 RX SOLUTION INTRAVENOUS Nov. 3, 2020 INCORPORATION OF THE LABELING REVISIONS PROVIDED FOR IN NDA 022253/S-039 AND NDA 022255/S-022 INTO THE LACOSAMIDE INJECTION LABELING
10MG/ML VIMPAT UCB INC N022255 April 20, 2010 RX SOLUTION ORAL Nov. 3, 2020 NEW PATIENT POPULATION

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

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Vimpat HUMAN PRESCRIPTION DRUG LABEL 1 0131-1810 INJECTION 10 mg INTRAVENOUS NDA 19 sections
Vimpat HUMAN PRESCRIPTION DRUG LABEL 2 0131-2470 KIT 50 mg None NDA 19 sections
Vimpat HUMAN PRESCRIPTION DRUG LABEL 2 0131-2470 KIT 100 mg None NDA 19 sections
Vimpat HUMAN PRESCRIPTION DRUG LABEL 1 0131-2477 TABLET, FILM COATED 50 mg ORAL NDA 19 sections
Vimpat HUMAN PRESCRIPTION DRUG LABEL 1 0131-2478 TABLET, FILM COATED 100 mg ORAL NDA 19 sections
Vimpat HUMAN PRESCRIPTION DRUG LABEL 1 0131-2479 TABLET, FILM COATED 150 mg ORAL NDA 19 sections
Vimpat HUMAN PRESCRIPTION DRUG LABEL 1 0131-2480 TABLET, FILM COATED 200 mg ORAL NDA 19 sections
Vimpat HUMAN PRESCRIPTION DRUG LABEL 1 0131-5410 SOLUTION 10 mg ORAL NDA 19 sections
Vimpat HUMAN PRESCRIPTION DRUG LABEL 1 54868-6077 TABLET, FILM COATED 50 mg ORAL NDA 18 sections
Lacosamide HUMAN PRESCRIPTION DRUG LABEL 1 63850-0053 TABLET, FILM COATED 50 mg ORAL ANDA 18 sections
Lacosamide HUMAN PRESCRIPTION DRUG LABEL 1 63850-0054 TABLET, FILM COATED 100 mg ORAL ANDA 18 sections
Lacosamide HUMAN PRESCRIPTION DRUG LABEL 1 63850-0055 TABLET, FILM COATED 150 mg ORAL ANDA 18 sections
Lacosamide HUMAN PRESCRIPTION DRUG LABEL 1 63850-0056 TABLET, FILM COATED 200 mg ORAL ANDA 18 sections
Lacosamide HUMAN PRESCRIPTION DRUG LABEL 1 65162-912 SOLUTION 10 mg ORAL ANDA 19 sections
Vimpat HUMAN PRESCRIPTION DRUG LABEL 1 70166-617 SOLUTION 10 mg ORAL NDA 19 sections
Vimpat HUMAN PRESCRIPTION DRUG LABEL 1 70518-0257 TABLET, FILM COATED 100 mg ORAL NDA 19 sections