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

Stem definition	Drug id	CAS RN
tyrosine kinase inhibitors	4318	850140-72-6

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: afatinib tovok afatinib dimaleate gilotrif BIBW2992 afatinib maleate	A quinazoline and butenamide derivative that acts as a tyrosine kinase inhibitor of epidermal growth factor receptors (ERBB RECEPTORS) and is used in the treatment of metastatic NON-SMALL CELL LUNG CANCER. Molecular weight: 485.94 Formula: C24H25ClFN5O3 CLOGP: 4.34 LIPINSKI: 0 HAC: 8 HDO: 2 TPSA: 88.61 ALOGS: -4.58 ROTB: 8 Status: ONP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

afatinib
tovok
afatinib dimaleate
gilotrif
BIBW2992
afatinib maleate

A quinazoline and butenamide derivative that acts as a tyrosine kinase inhibitor of epidermal growth factor receptors (ERBB RECEPTORS) and is used in the treatment of metastatic NON-SMALL CELL LUNG CANCER.

Molecular weight: 485.94
Formula: C24H25ClFN5O3
CLOGP: 4.34
LIPINSKI: 0
HAC: 8
HDO: 2
TPSA: 88.61
ALOGS: -4.58
ROTB: 8

Status: ONP

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

Drug dosage:

Dose	Unit	Route
40	mg	O

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	3	Hosey CM, Chan R, Benet LZ

Approvals:

Date	Agency	Company	Orphan
Sept. 25, 2013	EMA
July 12, 2013	FDA	BOEHRINGER INGELHEIM

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
Malignant neoplasm progression	1767.81	28.23	589	7855	67535	50529145
Diarrhoea	1204.21	28.23	888	7556	587588	50009092
Paronychia	779.08	28.23	175	8269	4389	50592291
Metastases to central nervous system	311.71	28.23	103	8341	11179	50585501
Stomatitis	293.22	28.23	192	8252	101152	50495528
Rash	223.60	28.23	316	8128	437155	50159525
Dermatitis acneiform	223.51	28.23	63	8381	3994	50592686
Decreased appetite	183.42	28.23	195	8249	200728	50395952
Dehydration	142.52	28.23	150	8294	152299	50444381
Metastases to meninges	137.59	28.23	37	8407	1965	50594715
Skin toxicity	129.48	28.23	41	8403	3872	50592808
Acne	98.05	28.23	53	8391	19542	50577138
EGFR gene mutation	96.99	28.23	19	8425	236	50596444
Dry skin	89.81	28.23	67	8377	43124	50553556
Pleural effusion	72.13	28.23	78	8366	81376	50515304
Skin fissures	65.51	28.23	31	8413	8637	50588043
Nail disorder	62.17	28.23	31	8413	9677	50587003
Mucosal inflammation	61.39	28.23	52	8392	40090	50556590
Skin disorder	58.41	28.23	41	8403	23989	50572691
Metastases to bone	56.49	28.23	36	8408	17959	50578721
Vomiting	55.92	28.23	186	8258	460572	50136108
Metastases to liver	55.24	28.23	37	8407	20067	50576613
Drug resistance	52.30	28.23	35	8409	18954	50577726
Metastases to lung	50.13	28.23	28	8416	10992	50585688
Interstitial lung disease	47.17	28.23	51	8393	53125	50543555
Death	46.39	28.23	139	8305	325240	50271440
Arthralgia	45.58	28.23	9	8435	438693	50157987
Small cell lung cancer	42.43	28.23	14	8430	1505	50595175
Cutaneous symptom	41.41	28.23	9	8435	191	50596489
Onychoclasis	37.48	28.23	18	8426	5178	50591502
Acquired gene mutation	37.26	28.23	11	8433	820	50595860
Gene mutation	36.65	28.23	12	8432	1259	50595421
Therapy partial responder	36.26	28.23	19	8425	6572	50590108
Oral pain	33.37	28.23	30	8414	25003	50571677
Nausea	31.59	28.23	213	8231	705185	49891495
Disease progression	31.53	28.23	57	8387	95809	50500871
Neoplasm progression	31.31	28.23	31	8413	29126	50567554
Pneumonitis	31	28.23	31	8413	29479	50567201
Rash pustular	30.93	28.23	17	8427	6464	50590216
Drug ineffective	29.35	28.23	58	8386	819275	49777405
Epistaxis	29.07	28.23	44	8400	63910	50532770
Condition aggravated	28.97	28.23	7	8437	297051	50299629

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
Malignant neoplasm progression	1266.62	34.93	452	3904	73407	29496764
Diarrhoea	577.10	34.93	433	3923	332265	29237906
Paronychia	354.09	34.93	83	4273	2870	29567301
Metastases to central nervous system	272.76	34.93	81	4275	7050	29563121
Rash	257.73	34.93	216	4140	189603	29380568
Stomatitis	223.92	34.93	109	4247	37004	29533167
EGFR gene mutation	128.46	34.93	21	4335	95	29570076
Dermatitis acneiform	109.26	34.93	38	4318	5453	29564718
Interstitial lung disease	90.79	34.93	72	4284	57646	29512525
Decreased appetite	80.99	34.93	103	4253	145239	29424932
Acne	55.16	34.93	27	4329	9193	29560978
Lymphangiosis carcinomatosa	52.82	34.93	14	4342	798	29569373
Skin toxicity	52.27	34.93	20	4336	3751	29566420
Metastases to meninges	51.76	34.93	15	4341	1190	29568981
Dehydration	45.28	34.93	69	4287	114679	29455492
Metastases to bone	44.74	34.93	24	4332	9874	29560297
Pleural effusion	39.94	34.93	51	4305	71857	29498314

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
Malignant neoplasm progression	2531.71	25.38	891	10718	111980	64375143
Diarrhoea	1524.00	25.38	1146	10463	721558	63765565
Paronychia	1014.95	25.38	235	11374	6257	64480866
Stomatitis	464.16	25.38	272	11337	109333	64377790
Metastases to central nervous system	446.92	25.38	145	11464	13767	64473356
Rash	419.07	25.38	460	11149	458089	64029034
Dermatitis acneiform	320.61	25.38	100	11509	8343	64478780
EGFR gene mutation	223.14	25.38	41	11568	323	64486800
Decreased appetite	221.26	25.38	262	11347	281027	64206096
Metastases to meninges	175.62	25.38	49	11560	2766	64484357
Skin toxicity	161.08	25.38	56	11553	6546	64480577
Dehydration	146.03	25.38	187	11422	216576	64270547
Acne	126.42	25.38	68	11541	23013	64464110
Interstitial lung disease	109.60	25.38	110	11499	97622	64389501
Dry skin	95.93	25.38	77	11532	51084	64436039
Metastases to bone	92.18	25.38	53	11556	20382	64466741
Pleural effusion	91.11	25.38	113	11496	126446	64360677
Metastases to liver	86.94	25.38	54	11555	23887	64463236
Nail disorder	78.78	25.38	36	11573	8588	64478535
Lymphangiosis carcinomatosa	75.12	25.38	23	11586	1798	64485325
Skin fissures	66.79	25.38	34	11575	10272	64476851
Small cell lung cancer	66.55	25.38	23	11586	2638	64484485
Drug resistance	66.14	25.38	53	11556	35049	64452074
Mucosal inflammation	62.08	25.38	66	11543	62518	64424605
Metastases to lung	62.01	25.38	37	11572	15227	64471896
Vomiting	57.51	25.38	223	11386	550894	63936229
Therapy partial responder	55.55	25.38	30	11579	10218	64476905
Skin disorder	52.58	25.38	42	11567	27638	64459485
Cutaneous symptom	48.33	25.38	12	11597	428	64486695
Rash pustular	48.24	25.38	27	11582	9858	64477265
Gene mutation	44.45	25.38	16	11593	2066	64485057
Arthralgia	41.46	25.38	14	11595	442246	64044877
Acquired gene mutation	41.42	25.38	15	11594	1971	64485152
Drug interaction	38.49	25.38	9	11600	362074	64125049
Nausea	37.90	25.38	256	11353	785544	63701579
Malignant neoplasm of pleura	37.05	25.38	8	11601	152	64486971
Condition aggravated	34.52	25.38	12	11597	372414	64114709
Death	34.06	25.38	174	11435	482531	64004592
Neoplasm progression	33.38	25.38	39	11570	40925	64446198
Drug ineffective	32.53	25.38	64	11545	840183	63646940
Onychoclasis	32.25	25.38	16	11593	4576	64482547
Metastases to pleura	31.90	25.38	11	11598	1253	64485870
Gastrointestinal toxicity	30.02	25.38	16	11593	5306	64481817
Dysgeusia	29.07	25.38	39	11570	47008	64440115
Angular cheilitis	27.93	25.38	8	11601	496	64486627
Small cell carcinoma	26.93	25.38	7	11602	301	64486822
Metastasis	26.28	25.38	15	11594	5680	64481443
Toxicity to various agents	25.62	25.38	17	11592	363496	64123627

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	L01EB03	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS PROTEIN KINASE INHIBITORS Epidermal growth factor receptor (EGFR) 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
CHEBI has role	CHEBI:35610	antineoplastic agents
CHEBI has role	CHEBI:38637	tyrosine kinase inhibitors

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

Disease	Relation	SNOMED_ID	DOID
Non-small cell lung cancer, positive for epidermal growth factor receptor expression	indication	426964009

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	11.1	acidic
pKa2	8.94	Basic
pKa3	4.09	Basic

Orange Book patent data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
EQ 20MG BASE	GILOTRIF	BOEHRINGER INGELHEIM	N201292	July 12, 2013	RX	TABLET	ORAL	9539258	Nov. 9, 2026	TREATMENT OF PATIENTS WITH ADVANCED (METASTATIC) NON-SMALL CELL LUNG CANCER WHOSE DISEASE PROGRESSED DURING OR AFTER PLATINUM-BASED CHEMOTHERAPY
EQ 30MG BASE	GILOTRIF	BOEHRINGER INGELHEIM	N201292	July 12, 2013	RX	TABLET	ORAL	9539258	Nov. 9, 2026	TREATMENT OF PATIENTS WITH ADVANCED (METASTATIC) NON-SMALL CELL LUNG CANCER WHOSE DISEASE PROGRESSED DURING OR AFTER PLATINUM-BASED CHEMOTHERAPY
EQ 40MG BASE	GILOTRIF	BOEHRINGER INGELHEIM	N201292	July 12, 2013	RX	TABLET	ORAL	9539258	Nov. 9, 2026	TREATMENT OF PATIENTS WITH ADVANCED (METASTATIC) NON-SMALL CELL LUNG CANCER WHOSE DISEASE PROGRESSED DURING OR AFTER PLATINUM-BASED CHEMOTHERAPY

Orange Book exclusivity data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
EQ 20MG BASE	GILOTRIF	BOEHRINGER INGELHEIM	N201292	July 12, 2013	RX	TABLET	ORAL	April 15, 2023	TREATMENT OF PATIENTS WITH METASTATIC, SQUAMOUS, NON-SMALL CELL LUNG CANCER PROGRESSING AFTER PLATINUM-BASED CHEMOTHERAPY
EQ 30MG BASE	GILOTRIF	BOEHRINGER INGELHEIM	N201292	July 12, 2013	RX	TABLET	ORAL	April 15, 2023	TREATMENT OF PATIENTS WITH METASTATIC, SQUAMOUS, NON-SMALL CELL LUNG CANCER PROGRESSING AFTER PLATINUM-BASED CHEMOTHERAPY
EQ 40MG BASE	GILOTRIF	BOEHRINGER INGELHEIM	N201292	July 12, 2013	RX	TABLET	ORAL	April 15, 2023	TREATMENT OF PATIENTS WITH METASTATIC, SQUAMOUS, NON-SMALL CELL LUNG CANCER PROGRESSING AFTER PLATINUM-BASED CHEMOTHERAPY
EQ 20MG BASE	GILOTRIF	BOEHRINGER INGELHEIM	N201292	July 12, 2013	RX	TABLET	ORAL	Oct. 15, 2023	PEDIATRIC EXCLUSIVITY
EQ 30MG BASE	GILOTRIF	BOEHRINGER INGELHEIM	N201292	July 12, 2013	RX	TABLET	ORAL	Oct. 15, 2023	PEDIATRIC EXCLUSIVITY
EQ 40MG BASE	GILOTRIF	BOEHRINGER INGELHEIM	N201292	July 12, 2013	RX	TABLET	ORAL	Oct. 15, 2023	PEDIATRIC EXCLUSIVITY
EQ 20MG BASE	GILOTRIF	BOEHRINGER INGELHEIM	N201292	July 12, 2013	RX	TABLET	ORAL	Jan. 12, 2025	FIRST-LINE TREATMENT OF METASTATIC NON-SMALL CELL LUNG CANCER WHOSE TUMORS HAVE NON-RESISTANT EPIDERMAL GROWTH FACTOR (EGFR) MUTATIONS OTHER THAN EXON 19 DELETIONS OR EXON 21 (L858R) SUBSTITUTION MUTATIONS AS DETECTED BY AN FDA-APPROVED TEST
EQ 30MG BASE	GILOTRIF	BOEHRINGER INGELHEIM	N201292	July 12, 2013	RX	TABLET	ORAL	Jan. 12, 2025	FIRST-LINE TREATMENT OF METASTATIC NON-SMALL CELL LUNG CANCER WHOSE TUMORS HAVE NON-RESISTANT EPIDERMAL GROWTH FACTOR (EGFR) MUTATIONS OTHER THAN EXON 19 DELETIONS OR EXON 21 (L858R) SUBSTITUTION MUTATIONS AS DETECTED BY AN FDA-APPROVED TEST
EQ 40MG BASE	GILOTRIF	BOEHRINGER INGELHEIM	N201292	July 12, 2013	RX	TABLET	ORAL	Jan. 12, 2025	FIRST-LINE TREATMENT OF METASTATIC NON-SMALL CELL LUNG CANCER WHOSE TUMORS HAVE NON-RESISTANT EPIDERMAL GROWTH FACTOR (EGFR) MUTATIONS OTHER THAN EXON 19 DELETIONS OR EXON 21 (L858R) SUBSTITUTION MUTATIONS AS DETECTED BY AN FDA-APPROVED TEST
EQ 20MG BASE	GILOTRIF	BOEHRINGER INGELHEIM	N201292	July 12, 2013	RX	TABLET	ORAL	July 12, 2025	PEDIATRIC EXCLUSIVITY
EQ 30MG BASE	GILOTRIF	BOEHRINGER INGELHEIM	N201292	July 12, 2013	RX	TABLET	ORAL	July 12, 2025	PEDIATRIC EXCLUSIVITY
EQ 40MG BASE	GILOTRIF	BOEHRINGER INGELHEIM	N201292	July 12, 2013	RX	TABLET	ORAL	July 12, 2025	PEDIATRIC EXCLUSIVITY

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	10	CHEMBL	CHEMBL
Receptor tyrosine-protein kinase erbB-4	Kinase	Q15303	ERBB4_HUMAN	INHIBITOR	Kd	8.20	CHEMBL	CHEMBL
Receptor tyrosine-protein kinase erbB-2	Kinase	P04626	ERBB2_HUMAN	INHIBITOR	Kd	8.30	CHEMBL	CHEMBL
Tyrosine-protein kinase Lck	Kinase	P06239	LCK_HUMAN		Kd	6.24	CHEMBL
Receptor-type tyrosine-protein kinase FLT3	Kinase	P36888	FLT3_HUMAN		Kd	5.85	CHEMBL
Phosphorylase b kinase gamma catalytic chain, liver/testis isoform	Kinase	P15735	PHKG2_HUMAN		Kd	6.33	CHEMBL
Myosin light chain kinase, smooth muscle	Kinase	Q15746	MYLK_HUMAN		Kd	4.50	CHEMBL
Tyrosine-protein kinase HCK	Kinase	P08631	HCK_HUMAN		Kd	5.66	CHEMBL
Mitogen-activated protein kinase 10	Kinase	P53779	MK10_HUMAN		Kd	5.70	CHEMBL
Hepatocyte growth factor receptor	Kinase	P08581	MET_HUMAN		Kd	5.66	CHEMBL
Phosphorylase b kinase gamma catalytic chain, skeletal muscle/heart isoform	Kinase	Q16816	PHKG1_HUMAN		Kd	5.89	CHEMBL
Serine/threonine-protein kinase 10	Kinase	O94804	STK10_HUMAN		Kd	5.37	CHEMBL
Mitogen-activated protein kinase 11	Kinase	Q15759	MK11_HUMAN		Kd	5.55	CHEMBL
Serine/threonine-protein kinase 17A	Kinase	Q9UEE5	ST17A_HUMAN		Kd	5.64	CHEMBL
Ephrin type-A receptor 6	Kinase	Q9UF33	EPHA6_HUMAN		Kd	6.47	CHEMBL
Casein kinase I isoform epsilon	Kinase	P49674	KC1E_HUMAN		Kd	5.89	CHEMBL
Mitogen-activated protein kinase 14	Kinase	Q16539	MK14_HUMAN		Kd	5.89	CHEMBL
Tyrosine-protein kinase FRK	Kinase	P42685	FRK_HUMAN		Kd	5.85	CHEMBL
Cyclin-G-associated kinase	Kinase	O14976	GAK_HUMAN		Kd	7.10	CHEMBL
Receptor-interacting serine/threonine-protein kinase 2	Kinase	O43353	RIPK2_HUMAN		Kd	5.57	CHEMBL
STE20-like serine/threonine-protein kinase	Kinase	Q9H2G2	SLK_HUMAN		Kd	5.43	CHEMBL
MAP kinase-interacting serine/threonine-protein kinase 2	Kinase	Q9HBH9	MKNK2_HUMAN		Kd	5.80	CHEMBL
Mitogen-activated protein kinase 9	Kinase	P45984	MK09_HUMAN		Kd	5.68	CHEMBL
MAP kinase-activated protein kinase 2	Kinase	P49137	MAPK2_HUMAN		Kd	6.09	CHEMBL
Tyrosine-protein kinase receptor UFO	Kinase	P30530	UFO_HUMAN		Kd	5.28	CHEMBL
Ribosomal protein S6 kinase alpha-6	Kinase	Q9UK32	KS6A6_HUMAN		Kd	5.51	CHEMBL
Tyrosine-protein kinase TXK	Kinase	P42681	TXK_HUMAN		Kd	5.51	CHEMBL
Dual specificity tyrosine-phosphorylation-regulated kinase 1B	Kinase	Q9Y463	DYR1B_HUMAN		Kd	5.55	CHEMBL
MAP kinase-interacting serine/threonine-protein kinase 1	Kinase	Q9BUB5	MKNK1_HUMAN		Kd	5.74	CHEMBL
Tyrosine-protein kinase Blk	Kinase	P51451	BLK_HUMAN		Kd	6.66	CHEMBL
Citron Rho-interacting kinase	Kinase	O14578	CTRO_HUMAN		Kd	5.54	CHEMBL
Dual specificity tyrosine-phosphorylation-regulated kinase 1A	Kinase	Q13627	DYR1A_HUMAN		Kd	6.01	CHEMBL
Dual specificity tyrosine-phosphorylation-regulated kinase 2	Kinase	Q92630	DYRK2_HUMAN		Kd	5.74	CHEMBL
Ephrin type-B receptor 6	Kinase	O15197	EPHB6_HUMAN		Kd	5.51	CHEMBL
Homeodomain-interacting protein kinase 4	Kinase	Q8NE63	HIPK4_HUMAN		Kd	6.44	CHEMBL
Interleukin-1 receptor-associated kinase 1	Kinase	P51617	IRAK1_HUMAN		Kd	6.62	CHEMBL
Receptor tyrosine-protein kinase erbB-3	Kinase	P21860	ERBB3_HUMAN		Kd	5.35	CHEMBL
Serine/threonine-protein kinase SBK1	Kinase	Q52WX2	SBK1_HUMAN		Kd	5.32	CHEMBL
Adenosine kinase	Kinase	P55263	ADK_HUMAN		Kd	5.46	CHEMBL
Dual specificity mitogen-activated protein kinase kinase 5	Kinase	Q13163	MP2K5_HUMAN		Kd	5.89	CHEMBL
Tyrosine-protein kinase ABL1	Kinase	P00519	ABL1_HUMAN		Kd	6.64	CHEMBL
Proto-oncogene tyrosine-protein kinase Src	Kinase	P12931	SRC_HUMAN		Kd	5.55	CHEMBL

External reference:

ID	Source
4032662	VUID
N0000188388	NUI
D09724	KEGG_DRUG
850140-73-7	SECONDARY_CAS_RN
4032662	VANDF
4032663	VANDF
C2987648	UMLSCUI
CHEBI:61390	CHEBI
0WM	PDB_CHEM_ID
CHEMBL1173655	ChEMBL_ID
D000077716	MESH_DESCRIPTOR_UI
DB08916	DRUGBANK_ID
5667	IUPHAR_LIGAND_ID
9230	INN_ID
41UD74L59M	UNII
10184653	PUBCHEM_CID
1430268	RXNORM
204142	MMSL
29566	MMSL
d08113	MMSL
015117	NDDF
015118	NDDF
703579002	SNOMEDCT_US
703580004	SNOMEDCT_US
703582007	SNOMEDCT_US
CHEMBL2105712	ChEMBL_ID
CHEMBL2347958	ChEMBL_ID

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Gilotrif	HUMAN PRESCRIPTION DRUG LABEL	1	0597-0137	TABLET, FILM COATED	30 mg	ORAL	NDA	31 sections
Gilotrif	HUMAN PRESCRIPTION DRUG LABEL	1	0597-0137	TABLET, FILM COATED	30 mg	ORAL	NDA	31 sections
Gilotrif	HUMAN PRESCRIPTION DRUG LABEL	1	0597-0138	TABLET, FILM COATED	40 mg	ORAL	NDA	31 sections
Gilotrif	HUMAN PRESCRIPTION DRUG LABEL	1	0597-0138	TABLET, FILM COATED	40 mg	ORAL	NDA	31 sections
Gilotrif	HUMAN PRESCRIPTION DRUG LABEL	1	0597-0141	TABLET, FILM COATED	20 mg	ORAL	NDA	31 sections
Gilotrif	HUMAN PRESCRIPTION DRUG LABEL	1	0597-0141	TABLET, FILM COATED	20 mg	ORAL	NDA	31 sections