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

Stem definition	Drug id	CAS RN
tyrosine kinase inhibitors	1548	231277-92-2

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: lapatinib tosilate hydrate lapatinib tosilate lapatinib GW 572016X tyverb lapatinib ditosylate GW572016F lapatinib ditosilate lapatinib ditosilate hydrate lapatinib ditosylate hydrate	A quinazoline derivative that inhibits EPIDERMAL GROWTH FACTOR RECEPTOR and HER2 (RECEPTOR, ERBB-2) tyrosine kinases. It is used for the treatment of advanced or metastatic breast cancer, where tumors overexpress HER2. Molecular weight: 581.06 Formula: C29H26ClFN4O4S CLOGP: 5.82 LIPINSKI: 2 HAC: 8 HDO: 2 TPSA: 106.35 ALOGS: -4.42 ROTB: 11 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

lapatinib tosilate hydrate
lapatinib tosilate
lapatinib
GW 572016X
tyverb
lapatinib ditosylate
GW572016F
lapatinib ditosilate
lapatinib ditosilate hydrate
lapatinib ditosylate hydrate

A quinazoline derivative that inhibits EPIDERMAL GROWTH FACTOR RECEPTOR and HER2 (RECEPTOR, ERBB-2) tyrosine kinases. It is used for the treatment of advanced or metastatic breast cancer, where tumors overexpress HER2.

Molecular weight: 581.06
Formula: C29H26ClFN4O4S
CLOGP: 5.82
LIPINSKI: 2
HAC: 8
HDO: 2
TPSA: 106.35
ALOGS: -4.42
ROTB: 11

Status: OFP

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

Drug dosage:

Dose	Unit	Route
1.25	g	O

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	2	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	0.00 mg/mL	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	1 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	30.73 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	0 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Approvals:

Date	Agency	Company	Orphan
June 10, 2008	EMA
March 13, 2007	FDA	NOVARTIS PHARMS CORP

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Palmar-plantar erythrodysaesthesia syndrome	1854.14	20.69	574	23090	22441	63442917
Diarrhoea	1520.82	20.69	1572	22092	713794	62751564
Disease progression	856.30	20.69	545	23119	122213	63343145
Metastases to central nervous system	646.51	20.69	226	23438	12879	63452479
Malignant neoplasm progression	394.13	20.69	290	23374	81831	63383527
Neutropenia	320.31	20.69	359	23305	174646	63290712
Paronychia	309.36	20.69	105	23559	5460	63459898
Metastases to liver	273.12	20.69	146	23518	23493	63441865
Metastases to lung	266.05	20.69	118	23546	12632	63452726
Dehydration	254.75	20.69	318	23346	173036	63292322
Metastases to bone	199.33	20.69	114	23550	20905	63444453
Ejection fraction decreased	190.29	20.69	113	23551	22219	63443139
Skin toxicity	186.12	20.69	69	23595	4645	63460713
Vomiting	181.71	20.69	537	23127	559080	62906278
Breast cancer metastatic	181.66	20.69	89	23575	11929	63453429
Blood bilirubin increased	166.38	20.69	126	23538	37014	63428344
Death	163.30	20.69	401	23263	373980	63091378
Metastases to lymph nodes	155.83	20.69	71	23593	8087	63457271
Mucosal inflammation	138.56	20.69	125	23539	46803	63418555
Skin fissures	136.18	20.69	72	23592	11316	63454042
Jaundice	132.69	20.69	100	23564	29151	63436207
Metastases to skin	123.18	20.69	39	23625	1624	63463734
Hypokalaemia	113.34	20.69	165	23499	103639	63361719
Gastrointestinal toxicity	110.07	20.69	55	23609	7686	63457672
Hepatic function abnormal	107.79	20.69	98	23566	37044	63428314
Dry skin	104.24	20.69	117	23547	56770	63408588
Hyperbilirubinaemia	100.95	20.69	59	23605	11255	63454103
Stomatitis	97.84	20.69	181	23483	138544	63326814
Rash	96.89	20.69	439	23225	560432	62904926
Nausea	96.36	20.69	594	23070	853877	62611481
Hepatotoxicity	92.65	20.69	90	23574	36951	63428407
Febrile neutropenia	87.88	20.69	158	23506	118291	63347067
Cardiotoxicity	86.01	20.69	48	23616	8390	63456968
Lymphangiosis carcinomatosa	83.18	20.69	28	23636	1417	63463941
Pyrexia	80.18	20.69	367	23297	470111	62995247
Alanine aminotransferase increased	78.99	20.69	140	23524	103630	63361728
Haematotoxicity	76.09	20.69	46	23618	9330	63456028
Decreased appetite	75.40	20.69	235	23429	250817	63214541
Condition aggravated	73.59	20.69	29	23635	402188	63063170
Drug hypersensitivity	72.44	20.69	14	23650	310673	63154685
Weight increased	66.95	20.69	9	23655	260783	63204575
Joint swelling	64.38	20.69	21	23643	327645	63137713
Drug ineffective	62.48	20.69	192	23472	1044573	62420785
Pleural effusion	59.95	20.69	117	23547	93093	63372265
Arthralgia	59.69	20.69	75	23589	569635	62895723
Therapeutic product effect decreased	59.57	20.69	3	23661	193184	63272174
Maternal exposure during pregnancy	55.52	20.69	8	23656	220054	63245304
Off label use	55.18	20.69	105	23559	674357	62791001
Dermatitis acneiform	52.50	20.69	29	23635	4967	63460391
Asthenia	51.56	20.69	280	23384	383324	63082034
Neoplasm progression	48.86	20.69	64	23600	36364	63428994
Glossodynia	48.80	20.69	5	23659	178871	63286487
Fall	48.42	20.69	45	23619	392289	63073069
Breast cancer	47.17	20.69	73	23591	48310	63417048
Aspartate aminotransferase increased	44.87	20.69	102	23562	90175	63375183
Skin exfoliation	44.80	20.69	67	23597	43035	63422323
Sinusitis	43.66	20.69	15	23649	226638	63238720
Metastasis	43.47	20.69	26	23638	5171	63460187
Completed suicide	42.66	20.69	3	23661	145670	63319688
Cellulitis	42.29	20.69	94	23570	81864	63383494
Superior vena cava syndrome	42.04	20.69	14	23650	685	63464673
Neurotoxicity	41.94	20.69	41	23623	16949	63448409
Biliary dilatation	40.98	20.69	19	23645	2250	63463108
Thrombocytopenia	40.32	20.69	136	23528	151021	63314337
Leukopenia	40.28	20.69	89	23575	77201	63388157
Pain	40.04	20.69	142	23522	740486	62724872
Musculoskeletal stiffness	39.60	20.69	10	23654	184608	63280750
Product dose omission issue	39.45	20.69	19	23645	234294	63231064
Neuropathy peripheral	39.35	20.69	112	23552	113555	63351803
Ascites	39.07	20.69	61	23603	40667	63424691
Neoplasm	37.55	20.69	27	23637	7318	63458040
Onychalgia	37.54	20.69	14	23650	957	63464401
Hypertension	36.89	20.69	30	23634	279273	63186085
Infusion related reaction	36.85	20.69	23	23641	245498	63219860
Wound	36.68	20.69	8	23656	163255	63302103
Discomfort	36.02	20.69	9	23655	167365	63297993
Transaminases	35.65	20.69	8	23656	84	63465274
Second primary malignancy	35.63	20.69	27	23637	7926	63457432
Therapeutic product effect incomplete	35.42	20.69	3	23661	125053	63340305
Metastatic neoplasm	34.66	20.69	21	23643	4274	63461084
Limbal stem cell deficiency	34.46	20.69	6	23658	13	63465345
Swelling	32.30	20.69	33	23631	275345	63190013
Radiation necrosis	32.11	20.69	10	23654	394	63464964
Erythema	31.95	20.69	140	23524	175611	63289747
Breast cancer recurrent	31.92	20.69	20	23644	4321	63461037
Feeling abnormal	31.89	20.69	8	23656	148384	63316974
Metastases to spine	31.80	20.69	18	23646	3231	63462127
Nail disorder	31.36	20.69	31	23633	12984	63452374
Recurrent cancer	30.87	20.69	15	23649	1972	63463386
Alopecia	30.73	20.69	49	23615	337487	63127871
Onycholysis	30.49	20.69	14	23650	1622	63463736
Left ventricular dysfunction	29.72	20.69	29	23635	11959	63453399
Asthma	29.16	20.69	6	23658	127555	63337803
Brain oedema	29.11	20.69	31	23633	14164	63451194
Breast neoplasm	29.04	20.69	13	23651	1419	63463939
Pericardial effusion	28.80	20.69	45	23619	30013	63435345
Exposure during pregnancy	28.74	20.69	11	23653	155536	63309822
Plantar erythema	28.51	20.69	8	23656	218	63465140
Treatment failure	28.03	20.69	20	23644	199023	63266335
Abdominal discomfort	27.89	20.69	48	23616	320837	63144521
Radiation pneumonitis	27.80	20.69	13	23651	1570	63463788
Nail infection	27.49	20.69	15	23649	2508	63462850
Drug interaction	27.38	20.69	27	23637	229104	63236254
Tumour marker increased	27.28	20.69	19	23645	4896	63460462
Performance status decreased	27.18	20.69	17	23647	3661	63461697
Mobility decreased	27.08	20.69	6	23658	121153	63344205
Neoplasm recurrence	26.86	20.69	15	23649	2623	63462735
Neoplasm malignant	26.27	20.69	43	23621	29818	63435540
Injection site pain	26.02	20.69	8	23656	129792	63335566
Gamma-glutamyltransferase increased	25.97	20.69	46	23618	33985	63431373
Contusion	25.50	20.69	12	23652	150032	63315326
Arthritis	25.39	20.69	6	23658	115915	63349443
Botryomycosis	25.36	20.69	5	23659	26	63465332
Lower respiratory tract infection	25.04	20.69	9	23655	132298	63333060
Central nervous system lesion	25.01	20.69	25	23639	10610	63454748
Vascular device infection	24.61	20.69	21	23643	7291	63458067
Brain neoplasm	24.52	20.69	17	23647	4349	63461009
Anal erythema	24.47	20.69	7	23657	205	63465153
Drug intolerance	24.32	20.69	49	23615	308612	63156746
Skin mass	24.02	20.69	19	23645	5936	63459422
Abdominal pain	23.88	20.69	189	23475	293267	63172091
Dyschezia	23.24	20.69	13	23651	2281	63463077
Product use issue	23.04	20.69	29	23635	220491	63244867
Ingrowing nail	22.45	20.69	13	23651	2436	63462922
Psoriasis	22.29	20.69	3	23661	86954	63378404
Lung infiltration	21.90	20.69	27	23637	14436	63450922
Metastases to meninges	21.72	20.69	13	23651	2589	63462769
Malignant pleural effusion	21.70	20.69	13	23651	2593	63462765
Hormone receptor positive breast cancer	21.61	20.69	8	23656	536	63464822
Bone cancer metastatic	21.40	20.69	6	23658	163	63465195
Osteonecrosis of jaw	21.25	20.69	43	23621	35080	63430278
Pneumonitis	21.16	20.69	43	23621	35179	63430179
Hyperhidrosis	20.98	20.69	7	23657	107829	63357529
Epistaxis	20.77	20.69	67	23597	72658	63392700

FDA Adverse Event Reporting System (Male)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Duodenal ulcer perforation	53.49	36.55	12	1095	1620	34954204
Diarrhoea	43.46	36.55	57	1050	389855	34565969
Metastases to lung	36.58	36.55	13	1094	9307	34946517

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Palmar-plantar erythrodysaesthesia syndrome	1166.08	20.25	381	15894	32753	79695360
Diarrhoea	1036.46	20.25	1066	15209	879423	78848690
Disease progression	549.36	20.25	384	15891	183978	79544135
Metastases to central nervous system	405.64	20.25	145	16130	16230	79711883
Malignant neoplasm progression	298.24	20.25	236	16039	135754	79592359
Metastases to lung	240.11	20.25	102	16173	18061	79710052
Metastases to liver	208.47	20.25	106	16169	28208	79699905
Dehydration	175.79	20.25	234	16041	247953	79480160
Paronychia	174.06	20.25	64	16211	7744	79720369
Breast cancer metastatic	164.43	20.25	63	16212	8539	79719574
Metastases to bone	155.60	20.25	83	16192	24344	79703769
Vomiting	142.30	20.25	374	15901	665454	79062659
Ejection fraction decreased	136.28	20.25	86	16189	34491	79693622
Metastases to skin	135.33	20.25	37	16238	1702	79726411
Metastases to lymph nodes	132.79	20.25	57	16218	10340	79717773
Gastrointestinal toxicity	122.14	20.25	50	16225	8059	79720054
Neutropenia	113.21	20.25	207	16068	287503	79440610
Skin toxicity	97.75	20.25	43	16232	8271	79719842
Skin fissures	93.44	20.25	48	16227	13025	79715088
Mucosal inflammation	91.50	20.25	94	16181	75486	79652627
Death	91.39	20.25	288	15987	566226	79161887
Hepatotoxicity	87.18	20.25	77	16198	51275	79676838
Hyperbilirubinaemia	81.92	20.25	55	16220	24463	79703650
Nausea	81.15	20.25	397	15878	956799	78771314
Hypokalaemia	78.44	20.25	120	16155	143920	79584193
Blood bilirubin increased	75.90	20.25	80	16195	66152	79661961
Jaundice	75.01	20.25	72	16203	53277	79674836
Lymphangiosis carcinomatosa	68.48	20.25	23	16252	2131	79725982
Rash	66.39	20.25	263	16012	578095	79150018
Cardiotoxicity	62.58	20.25	36	16239	12203	79715910
Haematotoxicity	62.12	20.25	39	16236	15480	79712633
Dry skin	58.88	20.25	71	16204	67924	79660189
Stomatitis	56.84	20.25	105	16170	146652	79581461
Condition aggravated	51.51	20.25	19	16256	501105	79227008
Asthenia	51.05	20.25	223	16052	511466	79216647
Dermatitis acneiform	39.71	20.25	25	16250	9968	79718145
Decreased appetite	39.38	20.25	156	16119	342262	79385851
Metastases to spine	37.17	20.25	18	16257	4306	79723807
Drug hypersensitivity	36.84	20.25	8	16267	298908	79429205
Onycholysis	35.35	20.25	14	16261	2069	79726044
Transaminases	35.19	20.25	7	16268	76	79728037
Weight increased	35.06	20.25	7	16268	277379	79450734
Biliary dilatation	34.67	20.25	15	16260	2771	79725342
Tumour marker increased	34.38	20.25	17	16258	4255	79723858
Onychalgia	33.60	20.25	11	16264	941	79727172
Limbal stem cell deficiency	33.32	20.25	6	16269	36	79728077
Drug interaction	33.19	20.25	22	16253	415161	79312952
Hepatic function abnormal	33.04	20.25	56	16219	73051	79655062
Abdominal pain	33.02	20.25	162	16113	389407	79338706
Metastasis	31.91	20.25	19	16256	6861	79721252
Fall	31.35	20.25	32	16243	487597	79240516
Breast cancer recurrent	30.54	20.25	14	16261	2963	79725150
Hormone receptor positive breast cancer	29.45	20.25	8	16267	359	79727754
Neoplasm progression	29.43	20.25	44	16231	51638	79676475
Second primary malignancy	29.43	20.25	24	16251	14326	79713787
Pyrexia	28.03	20.25	235	16040	678474	79049639
Osteonecrosis of jaw	27.82	20.25	39	16236	43187	79684926
Pleural effusion	27.17	20.25	78	16197	145184	79582929
Breast cancer	27.17	20.25	34	16241	33747	79694366
Neurotoxicity	26.59	20.25	33	16242	32485	79695628
Recurrent cancer	25.56	20.25	12	16263	2681	79725432
Metastases to the mediastinum	25.43	20.25	8	16267	602	79727511
Joint swelling	24.86	20.25	14	16261	288632	79439481
Botryomycosis	24.75	20.25	5	16270	59	79728054
Arthralgia	23.62	20.25	51	16224	571752	79156361
Metastatic neoplasm	23.58	20.25	14	16261	5028	79723085
Cholangitis	23.36	20.25	20	16255	12756	79715357
Hypertension	23.28	20.25	20	16255	330972	79397141
Left ventricular dysfunction	23.26	20.25	24	16251	19337	79708776
Neoplasm recurrence	23.17	20.25	13	16262	4201	79723912
Pericardial effusion	23.01	20.25	37	16238	46200	79681913
Central nervous system lesion	22.58	20.25	20	16255	13348	79714765
Skin mass	22.04	20.25	16	16259	8047	79720066
Alanine aminotransferase increased	21.92	20.25	78	16197	162492	79565621
Neuropathy peripheral	21.86	20.25	71	16204	141234	79586879
Cellulitis	21.80	20.25	60	16215	109000	79619113
Drug ineffective	21.58	20.25	131	16144	1080782	78647331
Infusion related reaction	21.56	20.25	10	16265	230227	79497886
Disease recurrence	21.55	20.25	35	16240	44074	79684039
Product dose omission issue	21.32	20.25	12	16263	247525	79480588
Radiation pneumonitis	21.26	20.25	12	16263	3921	79724192
Plantar erythema	21.19	20.25	6	16269	314	79727799
Performance status decreased	21.10	20.25	14	16261	6099	79722014
Gastric neoplasm	20.47	20.25	6	16269	355	79727758
Neoplasm	20.30	20.25	16	16259	9100	79719013

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	L01EH01	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS PROTEIN KINASE INHIBITORS Human epidermal growth factor receptor 2 (HER2) tyrosine kinase inhibitors
FDA MoA	N0000175076	Protein Kinase Inhibitors
MeSH PA	D000970	Antineoplastic Agents
MeSH PA	D004791	Enzyme Inhibitors
MeSH PA	D047428	Protein Kinase Inhibitors
FDA EPC	N0000175605	Kinase Inhibitor

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

Disease	Relation	SNOMED_ID
HER2-positive carcinoma of breast	indication	427685000
Torsades de pointes	contraindication	31722008
Hypokalemia	contraindication	43339004
Hepatic failure	contraindication	59927004
Interstitial pneumonia	contraindication	64667001
Left heart failure	contraindication	85232009
Prolonged QT interval	contraindication	111975006
Liver function tests abnormal	contraindication	166603001
Hypomagnesemia	contraindication	190855004
Drug-induced hepatitis	contraindication	235876009
Pregnancy, function	contraindication	289908002
Severe diarrhea	contraindication	409587002
Breastfeeding (mother)	contraindication	413712001
Congenital long QT syndrome	contraindication	442917000

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	5.62	Basic
pKa2	4.99	Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Epidermal growth factor receptor	Kinase	P00533	EGFR_HUMAN	INHIBITOR	Kd	9.04	CHEMBL	CHEMBL
Receptor tyrosine-protein kinase erbB-2	Kinase	P04626	ERBB2_HUMAN	INHIBITOR	Kd	8.15	CHEMBL	CHEMBL
Platelet-derived growth factor receptor beta	Kinase	P09619	PGFRB_HUMAN		IC50	5.07	CHEMBL
Tyrosine-protein kinase ABL1	Kinase	P00519	ABL1_HUMAN		IC50	4.64	CHEMBL
Solute carrier organic anion transporter family member 1B1	Transporter	Q9Y6L6	SO1B1_HUMAN				WOMBAT-PK
Cyclin-dependent kinase 2	Kinase	P24941	CDK2_HUMAN		IC50	4.96	CHEMBL
Insulin receptor	Kinase	P06213	INSR_HUMAN	AGONIST	IC50	4.77	CHEMBL
Receptor tyrosine-protein kinase erbB-4	Kinase	Q15303	ERBB4_HUMAN		Kd	7.27	CHEMBL
Serine/threonine-protein kinase 10	Kinase	O94804	STK10_HUMAN		Kd	5.59	CHEMBL
Receptor-interacting serine/threonine-protein kinase 2	Kinase	O43353	RIPK2_HUMAN		Kd	5.44	CHEMBL
STE20-like serine/threonine-protein kinase	Kinase	Q9H2G2	SLK_HUMAN		Kd	5.48	CHEMBL
Dual specificity mitogen-activated protein kinase kinase 7	Kinase	O14733	MP2K7_HUMAN		Kd	5.36	CHEMBL
Receptor tyrosine-protein kinase erbB-3	Kinase	P21860	ERBB3_HUMAN		Kd	5.26	CHEMBL
Phosphatidylinositol 4-phosphate 3-kinase C2 domain-containing subunit beta	Kinase	O00750	P3C2B_HUMAN		Kd	6.17	CHEMBL
Phosphatidylinositol 4-phosphate 3-kinase C2 domain-containing subunit gamma	Kinase	O75747	P3C2G_HUMAN		Kd	5.12	CHEMBL
Phosphatidylinositol 4-kinase beta	Kinase	Q9UBF8	PI4KB_HUMAN		Kd	6.03	CHEMBL
Multidrug resistance protein 1	Transporter	P08183	MDR1_HUMAN				WOMBAT-PK
Dual specificity mitogen-activated protein kinase kinase 5	Kinase	Q13163	MP2K5_HUMAN		Kd	5.96	CHEMBL
ATP-binding cassette sub-family G member 2	Transporter	Q9UNQ0	ABCG2_HUMAN				WOMBAT-PK
Tubulin alpha-1A chain	Structural		TBA1A_RAT		Kd	7.27	CHEMBL

External reference:

ID	Source
4026029	VUID
N0000179782	NUI
D04024	KEGG_DRUG
388082-78-8	SECONDARY_CAS_RN
4026029	VANDF
C1506770	UMLSCUI
FMM	PDB_CHEM_ID
CHEMBL554	ChEMBL_ID
CHEMBL1201179	ChEMBL_ID
D000077341	MESH_DESCRIPTOR_UI
DB01259	DRUGBANK_ID
5692	IUPHAR_LIGAND_ID
8378	INN_ID
0VUA21238F	UNII
208908	PUBCHEM_CID
480167	RXNORM
339254	MMSL
d06672	MMSL
012020	NDDF
012022	NDDF
425466009	SNOMEDCT_US
425820005	SNOMEDCT_US
426238006	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
TYKERB	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0671	TABLET	250 mg	ORAL	NDA	34 sections
TYKERB	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0671	TABLET	250 mg	ORAL	NDA	34 sections
TYKERB	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0671	TABLET	250 mg	ORAL	NDA	34 sections
Lapatinib	Human Prescription Drug Label	1	68180-801	TABLET	250 mg	ORAL	ANDA	28 sections
Lapatinib	Human Prescription Drug Label	1	68180-801	TABLET	250 mg	ORAL	ANDA	28 sections