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

Stem definition	Drug id	CAS RN
serotonin receptor antagonists (mostly 5-HT2)	5142	706779-91-1

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: pimavanserin pimavanserin tartrate ACP-103 nuplazid	an atypical antipsychotic, mechanism of action of pimavanserin in the treatment of hallucinations and delusions associated with Parkinson's disease psychosis is unknown. however, the effect of pimavanserin could be mediated through a combination of inverse agonist and antagonist activity at serotonin 5-HT2A receptors and to a lesser extent at serotonin 5-HT2C receptors Molecular weight: 427.56 Formula: C25H34FN3O2 CLOGP: 4.11 LIPINSKI: 0 HAC: 5 HDO: 1 TPSA: 44.81 ALOGS: -4.76 ROTB: 8 Status: ONP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

pimavanserin
pimavanserin tartrate
ACP-103
nuplazid

an atypical antipsychotic, mechanism of action of pimavanserin in the treatment of hallucinations and delusions associated with Parkinson's disease psychosis is unknown. however, the effect of pimavanserin could be mediated through a combination of inverse agonist and antagonist activity at serotonin 5-HT2A receptors and to a lesser extent at serotonin 5-HT2C receptors

Molecular weight: 427.56
Formula: C25H34FN3O2
CLOGP: 4.11
LIPINSKI: 0
HAC: 5
HDO: 1
TPSA: 44.81
ALOGS: -4.76
ROTB: 8

Status: ONP

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

Drug dosage:

None

ADMET properties:

None

Approvals:

Date	Agency	Company	Orphan
April 29, 2016	FDA	ACADIA PHARMACEUTICALS INC

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
Hallucination	3963.90	44.07	1119	12502	45538	50545965
Death	1511.83	44.07	983	12638	324396	50267107
Underdose	830.80	44.07	280	13341	19998	50571505
Prescribed underdose	691.83	44.07	230	13391	15719	50575784
Hallucination, visual	524.69	44.07	189	13432	16393	50575110
Nonspecific reaction	510.83	44.07	114	13507	1665	50589838
Product dose omission issue	496.35	44.07	403	13218	183435	50408068
Drug ineffective	435.10	44.07	778	12843	818555	49772948
Confusional state	407.96	44.07	362	13259	185566	50405937
Abnormal behaviour	367.85	44.07	153	13468	19505	50571998
Delusion	234.45	44.07	93	13528	10476	50581027
Adverse drug reaction	231.08	44.07	158	13463	55064	50536439
Fall	224.33	44.07	355	13266	334577	50256926
Aggression	198.54	44.07	102	13519	21014	50570489
Dementia	188.16	44.07	90	13531	15907	50575596
Dementia with Lewy bodies	172.96	44.07	34	13587	254	50591249
Somnolence	154.55	44.07	199	13422	154786	50436717
Peripheral swelling	141.10	44.07	221	13400	205715	50385788
Paranoia	130.19	44.07	61	13560	10287	50581216
Therapeutic response unexpected	130	44.07	70	13551	15845	50575658
Gait disturbance	115.38	44.07	170	13451	149835	50441668
Nightmare	112.84	44.07	64	13557	16022	50575481
Inappropriate schedule of product administration	106.16	44.07	113	13508	71718	50519785
Urinary tract infection	100.82	44.07	200	13421	223820	50367683
Metabolic function test abnormal	95.94	44.07	19	13602	148	50591355
Abnormal dreams	93.04	44.07	47	13574	9330	50582173
Hypersomnia	81.49	44.07	51	13570	15263	50576240
Psychotic disorder	78.53	44.07	57	13564	21755	50569748
Hip fracture	78.33	44.07	61	13560	25870	50565633
Hospitalisation	70.31	44.07	89	13532	67848	50523655
Pyrexia	69.39	44.07	10	13611	380193	50211310
Arthralgia	66.59	44.07	18	13603	438684	50152819
Screaming	65.29	44.07	26	13595	2952	50588551
Agitation	65.10	44.07	76	13545	53308	50538195
Tremor	60.73	44.07	110	13511	114793	50476710
Pain	57.93	44.07	43	13578	578860	50012643
Insomnia	57.82	44.07	138	13483	174727	50416776
Freezing phenomenon	57.67	44.07	18	13603	997	50590506
Dysphagia	56.82	44.07	86	13535	77432	50514071
Balance disorder	52.71	44.07	79	13542	70511	50520992
Cognitive disorder	50.78	44.07	61	13560	44062	50547441
Drug hypersensitivity	47.17	44.07	6	13615	251004	50340499
Sleep terror	46.06	44.07	14	13607	709	50590794
Diarrhoea	45.62	44.07	55	13566	588421	50003082
Hallucination, auditory	45.50	44.07	31	13590	10697	50580806
Dysstasia	45.49	44.07	38	13583	17781	50573722
Anaemia	45.18	44.07	7	13614	252449	50339054

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
Hallucination	5992.18	52.11	1936	20713	42776	29509102
Death	2270.74	52.11	1940	20709	340144	29211734
Prescribed underdose	1195.33	52.11	377	22272	7409	29544469
Underdose	1164.36	52.11	410	22239	11459	29540419
Confusional state	1038.62	52.11	823	21826	127054	29424824
Nonspecific reaction	854.15	52.11	194	22455	957	29550921
Abnormal behaviour	699.51	52.11	345	22304	22782	29529096
Product dose omission issue	657.97	52.11	562	22087	95821	29456057
Hallucination, visual	588.82	52.11	268	22381	14747	29537131
Drug ineffective	529.40	52.11	969	21680	362201	29189677
Adverse drug reaction	429.80	52.11	253	22396	23767	29528111
Fall	410.04	52.11	585	22064	176593	29375285
Peripheral swelling	372.57	52.11	341	22308	63398	29488480
Gait disturbance	366.99	52.11	360	22289	72989	29478889
Dementia	361.24	52.11	177	22472	11481	29540397
Aggression	352.92	52.11	259	22390	35282	29516596
Therapeutic response unexpected	291.27	52.11	139	22510	8499	29543379
Delusion	285.18	52.11	149	22500	11067	29540811
Somnolence	272.57	52.11	347	22302	93608	29458270
Gait inability	217.08	52.11	149	22500	18226	29533652
Hypersomnia	207.31	52.11	119	22530	10635	29541243
Agitation	199.00	52.11	220	22429	51084	29500794
Nightmare	198.09	52.11	118	22531	11299	29540579
Dysstasia	183.66	52.11	109	22540	10365	29541513
Acute kidney injury	163.86	52.11	10	22639	265257	29286621
Dementia with Lewy bodies	163.60	52.11	46	22603	592	29551286
Paranoia	160.78	52.11	98	22551	9779	29542099
Inappropriate schedule of product administration	157.57	52.11	182	22467	44290	29507588
Pyrexia	139.55	52.11	26	22623	287596	29264282
Posture abnormal	137.80	52.11	53	22596	1894	29549984
Metabolic function test abnormal	134.26	52.11	25	22624	31	29551847
Hospitalisation	131.66	52.11	169	22480	45819	29506059
Anaemia	125.74	52.11	7	22642	200944	29350934
Drooling	124.83	52.11	56	22593	2965	29548913
Insomnia	123.85	52.11	234	22415	88527	29463351
Balance disorder	118.07	52.11	142	22507	36028	29515850
Abnormal dreams	116.05	52.11	70	22579	6850	29545028
Cognitive disorder	112.80	52.11	113	22536	23386	29528492
Psychotic disorder	109.14	52.11	104	22545	20250	29531628
Feeling abnormal	93.15	52.11	157	22492	54288	29497590
Dysphagia	92.13	52.11	157	22492	54769	29497109
Neutropenia	87.53	52.11	3	22646	131708	29420170
Anger	85.22	52.11	69	22580	10821	29541057
Dyspnoea	79.64	52.11	80	22569	326652	29225226
Hip fracture	78.99	52.11	65	22584	10427	29541451
Urinary tract infection	76.28	52.11	170	22479	72184	29479694
Tremor	75.53	52.11	171	22478	73367	29478511
Intentional underdose	74.46	52.11	25	22624	598	29551280
Disorientation	71.44	52.11	100	22549	29415	29522463
Constipation	68.99	52.11	218	22431	113942	29437936
Arthralgia	68.88	52.11	12	22637	139605	29412273
Speech disorder	68.14	52.11	87	22562	23429	29528449
Freezing phenomenon	63.87	52.11	27	22622	1236	29550642
Abdominal pain	63.85	52.11	13	22636	135344	29416534
Diarrhoea	62.74	52.11	99	22550	332599	29219279
Restlessness	61.14	52.11	80	22569	22065	29529813
Drug interaction	58.26	52.11	40	22609	197345	29354533
Screaming	57.15	52.11	25	22624	1245	29550633
Memory impairment	56.88	52.11	101	22548	36369	29515509
Completed suicide	53.81	52.11	4	22645	90242	29461636

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
Hallucination	5253.47	43.14	1654	22026	71134	64403918
Death	4018.55	43.14	2355	21325	480350	63994702
Underdose	1501.15	43.14	501	23179	25328	64449724
Prescribed underdose	1259.05	43.14	402	23278	17613	64457439
Confusional state	954.59	43.14	777	22903	260367	64214685
Product dose omission issue	768.90	43.14	607	23073	194140	64280912
Abnormal behaviour	742.55	43.14	322	23358	33300	64441752
Nonspecific reaction	686.34	43.14	157	23523	1846	64473206
Hallucination, visual	612.57	43.14	266	23414	27568	64447484
Fall	493.16	43.14	680	23000	416146	64058906
Aggression	465.04	43.14	259	23421	45973	64429079
Dementia	362.84	43.14	169	23511	20597	64454455
Delusion	347.33	43.14	157	23523	17857	64457195
Somnolence	314.56	43.14	380	23300	203265	64271787
Gait disturbance	310.56	43.14	348	23332	171807	64303245
Therapeutic response unexpected	265.21	43.14	128	23552	16873	64458179
Hypersomnia	253.01	43.14	130	23550	19587	64455465
Metabolic function test abnormal	240.95	43.14	44	23636	141	64474911
Adverse drug reaction	234.79	43.14	167	23513	45297	64429755
Agitation	213.44	43.14	209	23471	88158	64386894
Peripheral swelling	209.05	43.14	316	23364	208837	64266215
Drug ineffective	194.65	43.14	711	22969	839536	63635516
Paranoia	184.66	43.14	99	23581	16253	64458799
Inappropriate schedule of product administration	180.71	43.14	195	23485	92091	64382961
Gait inability	170.42	43.14	134	23546	42234	64432818
Dysstasia	169.91	43.14	106	23574	23109	64451943
Abnormal dreams	164.60	43.14	79	23601	10277	64464775
Psychotic disorder	162.49	43.14	120	23560	34458	64440594
Dementia with Lewy bodies	161.80	43.14	40	23640	667	64474385
Nightmare	148.97	43.14	94	23586	20899	64454153
Acute kidney injury	133.25	43.14	8	23672	449232	64025820
Cognitive disorder	132.36	43.14	130	23550	54957	64420095
Hip fracture	124.96	43.14	93	23587	27006	64448046
Posture abnormal	124.75	43.14	47	23633	3359	64471693
Drooling	120.67	43.14	52	23628	5267	64469785
Pyrexia	120.03	43.14	29	23651	558615	63916437
Balance disorder	113.79	43.14	147	23533	83779	64391273
Insomnia	111.77	43.14	233	23447	197603	64277449
Anger	110.46	43.14	70	23610	15671	64459381
Anaemia	105.75	43.14	9	23671	378671	64096381
Urinary tract infection	101.99	43.14	247	23433	231349	64243703
Dysphagia	96.15	43.14	154	23526	106658	64368394
Sedation	90.67	43.14	93	23587	41369	64433683
Tremor	90.07	43.14	180	23500	148050	64327002
Arthralgia	89.14	43.14	26	23654	442234	64032818
Freezing phenomenon	81.74	43.14	28	23652	1518	64473534
Motor dysfunction	80.85	43.14	51	23629	11322	64463730
Orthostatic hypotension	78.09	43.14	91	23589	46647	64428405
Disorientation	77.54	43.14	99	23581	55729	64419323
Speech disorder	77.10	43.14	92	23588	48349	64426703
Hospitalisation	76.84	43.14	115	23565	75092	64399960
Neutropenia	74.99	43.14	3	23677	239621	64235431
Feeling abnormal	73.79	43.14	156	23524	133446	64341606
Pain	72.94	43.14	58	23622	553453	63921599
Intentional underdose	70.33	43.14	27	23653	2031	64473021
Completed suicide	69.59	43.14	3	23677	224411	64250641
Screaming	68.74	43.14	31	23649	3498	64471554
Dyspnoea	63.57	43.14	104	23576	718570	63756482
Abdominal pain	63.55	43.14	18	23662	312357	64162695
Patient elopement	59.61	43.14	9	23671	3	64475049
Incoherent	58.45	43.14	35	23645	7083	64467969
Diarrhoea	57.24	43.14	112	23568	722592	63752460
Restlessness	55.94	43.14	71	23609	39714	64435338
Constipation	55.78	43.14	198	23482	229139	64245913
Drug hypersensitivity	55.77	43.14	10	23670	237805	64237247
Haemoglobin decreased	53.40	43.14	5	23675	195058	64279994
Drug interaction	50.11	43.14	36	23644	362047	64113005
Memory impairment	49.55	43.14	102	23578	85580	64389472
Rapid eye movement sleep behaviour disorder	47.49	43.14	13	23667	328	64474724
Pruritus	47.37	43.14	28	23652	312372	64162680
White blood cell count decreased	46.13	43.14	3	23677	157834	64317218
Sleep terror	45.59	43.14	17	23663	1180	64473872
Hypokinesia	45.20	43.14	42	23638	16554	64458498
Vomiting	44.79	43.14	84	23596	551033	63924019
Unresponsive to stimuli	44.40	43.14	72	23608	50321	64424731
Belligerence	44.01	43.14	12	23668	298	64474754
Refusal of treatment by patient	43.85	43.14	31	23649	8308	64466744

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	N05AX17	NERVOUS SYSTEM PSYCHOLEPTICS ANTIPSYCHOTICS Other antipsychotics
FDA EPC	N0000175430	Atypical Antipsychotic
MeSH PA	D018726	Anti-Dyskinesia Agents
MeSH PA	D000978	Antiparkinson Agents
MeSH PA	D014150	Antipsychotic Agents
MeSH PA	D002491	Central Nervous System Agents
MeSH PA	D002492	Central Nervous System Depressants
MeSH PA	D018377	Neurotransmitter Agents
MeSH PA	D011619	Psychotropic Drugs
MeSH PA	D058830	Serotonin 5-HT2 Receptor Antagonists
MeSH PA	D018490	Serotonin Agents
MeSH PA	D012702	Serotonin Antagonists
MeSH PA	D014149	Tranquilizing Agents
CHEBI has role	CHEBI:35476	neuroleptics
CHEBI has role	CHEBI:48279	serotonin antagonists
CHEBI has role	CHEBI:133016	5-hydroxytryptamine (2A) receptor inverse agonist

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

Disease	Relation	SNOMED_ID	DOID
Parkinson's disease	indication	49049000	DOID:14330

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	8.42	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 10MG BASE	NUPLAZID	ACADIA PHARMS INC	N207318	June 28, 2018	RX	TABLET	ORAL	9765053	July 27, 2022	TREATMENT OF HALLUCINATIONS AND DELUSIONS ASSOCIATED WITH PARKINSONS DISEASE PSYCHOSIS
EQ 17MG BASE	NUPLAZID	ACADIA PHARMS INC	N207318	April 29, 2016	DISCN	TABLET	ORAL	9765053	July 27, 2022	TREATMENT OF HALLUCINATIONS AND DELUSIONS ASSOCIATED WITH PARKINSONS DISEASE PSYCHOSIS
EQ 34MG BASE	NUPLAZID	ACADIA PHARMS INC	N210793	June 28, 2018	RX	CAPSULE	ORAL	9765053	July 27, 2022	TREATMENT OF HALLUCINATIONS AND DELUSIONS ASSOCIATED WITH PARKINSONS DISEASE PSYCHOSIS
EQ 10MG BASE	NUPLAZID	ACADIA PHARMS INC	N207318	June 28, 2018	RX	TABLET	ORAL	10028944	Jan. 15, 2024	TREATMENT OF HALLUCINATIONS AND DELUSIONS ASSOCIATED WITH PARKINSONS DISEASE PSYCHOSIS
EQ 10MG BASE	NUPLAZID	ACADIA PHARMS INC	N207318	June 28, 2018	RX	TABLET	ORAL	8618130	Jan. 15, 2024	TREATMENT OF PSYCHOSIS OR A SYMPTOM THEREOF
EQ 10MG BASE	NUPLAZID	ACADIA PHARMS INC	N207318	June 28, 2018	RX	TABLET	ORAL	8921393	Jan. 15, 2024	TREATMENT OF A NEURODEGENERATIVE DISEASE OR A SYMPTOM THEREOF
EQ 10MG BASE	NUPLAZID	ACADIA PHARMS INC	N207318	June 28, 2018	RX	TABLET	ORAL	9566271	Jan. 15, 2024	TREATMENT OF HALLUCINATIONS AND DELUSIONS ASSOCIATED WITH PARKINSONS DISEASE PSYCHOSIS
EQ 17MG BASE	NUPLAZID	ACADIA PHARMS INC	N207318	April 29, 2016	DISCN	TABLET	ORAL	10028944	Jan. 15, 2024	TREATMENT OF HALLUCINATIONS AND DELUSIONS ASSOCIATED WITH PARKINSONS DISEASE PSYCHOSIS
EQ 17MG BASE	NUPLAZID	ACADIA PHARMS INC	N207318	April 29, 2016	DISCN	TABLET	ORAL	8618130	Jan. 15, 2024	TREATMENT OF PSYCHOSIS OR A SYMPTOM THEREOF
EQ 17MG BASE	NUPLAZID	ACADIA PHARMS INC	N207318	April 29, 2016	DISCN	TABLET	ORAL	8921393	Jan. 15, 2024	TREATMENT OF A NEURODEGENERATIVE DISEASE OR A SYMPTOM THEREOF
EQ 17MG BASE	NUPLAZID	ACADIA PHARMS INC	N207318	April 29, 2016	DISCN	TABLET	ORAL	9566271	Jan. 15, 2024	TREATMENT OF HALLUCINATIONS AND DELUSIONS ASSOCIATED WITH PARKINSONS DISEASE PSYCHOSIS
EQ 34MG BASE	NUPLAZID	ACADIA PHARMS INC	N210793	June 28, 2018	RX	CAPSULE	ORAL	10028944	Jan. 15, 2024	TREATMENT OF HALLUCINATIONS AND DELUSIONS ASSOCIATED WITH PARKINSONS DISEASE PSYCHOSIS
EQ 34MG BASE	NUPLAZID	ACADIA PHARMS INC	N210793	June 28, 2018	RX	CAPSULE	ORAL	8618130	Jan. 15, 2024	TREATMENT OF PSYCHOSIS OR A SYMPTOM THEREOF
EQ 34MG BASE	NUPLAZID	ACADIA PHARMS INC	N210793	June 28, 2018	RX	CAPSULE	ORAL	8921393	Jan. 15, 2024	TREATMENT OF A NEURODEGENERATIVE DISEASE OR A SYMPTOM THEREOF
EQ 34MG BASE	NUPLAZID	ACADIA PHARMS INC	N210793	June 28, 2018	RX	CAPSULE	ORAL	9566271	Jan. 15, 2024	TREATMENT OF HALLUCINATIONS AND DELUSIONS ASSOCIATED WITH PARKINSONS DISEASE PSYCHOSIS
EQ 10MG BASE	NUPLAZID	ACADIA PHARMS INC	N207318	June 28, 2018	RX	TABLET	ORAL	7659285	Aug. 24, 2026	TREATMENT OF PARKINSONS DISEASE PSYCHOSIS
EQ 17MG BASE	NUPLAZID	ACADIA PHARMS INC	N207318	April 29, 2016	DISCN	TABLET	ORAL	7659285	Aug. 24, 2026	TREATMENT OF PARKINSONS DISEASE PSYCHOSIS
EQ 34MG BASE	NUPLAZID	ACADIA PHARMS INC	N210793	June 28, 2018	RX	CAPSULE	ORAL	7659285	Aug. 24, 2026	TREATMENT OF PARKINSONS DISEASE PSYCHOSIS
EQ 10MG BASE	NUPLAZID	ACADIA PHARMS INC	N207318	June 28, 2018	RX	TABLET	ORAL	10517860	March 23, 2037	TREATMENT OF HALLUCINATIONS AND DELUSIONS ASSOCIATED WITH PARKINSONS DISEASE PSYCHOSIS
EQ 10MG BASE	NUPLAZID	ACADIA PHARMS INC	N207318	June 28, 2018	RX	TABLET	ORAL	10953000	March 23, 2037	TREATMENT OF HALLUCINATIONS AND DELUSIONS ASSOCIATED WITH PARKINSONS DISEASE PSYCHOSIS
EQ 34MG BASE	NUPLAZID	ACADIA PHARMS INC	N210793	June 28, 2018	RX	CAPSULE	ORAL	10849891	Aug. 27, 2038	TREATMENT OF HALLUCINATIONS AND DELUSIONS ASSOCIATED WITH PARKINSONS DISEASE PSYCHOSIS

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
5-hydroxytryptamine receptor 2A	GPCR	P28223	5HT2A_HUMAN	INVERSE AGONIST	Ki	9.30		SCIENTIFIC LITERATURE	DRUG LABEL
5-hydroxytryptamine receptor 2C	GPCR	P28335	5HT2C_HUMAN	INVERSE AGONIST	Ki	8.80		SCIENTIFIC LITERATURE

External reference:

ID	Source
JZ963P0DIK	UNII
4035717	VANDF
C1722267	UMLSCUI
CHEBI:133017	CHEBI
CHEMBL2111101	ChEMBL_ID
D08969	KEGG_DRUG
10071196	PUBCHEM_CID
DB05316	DRUGBANK_ID
CHEMBL2448613	ChEMBL_ID
8877	INN_ID
8423	IUPHAR_LIGAND_ID
1791685	RXNORM
240624	MMSL
31639	MMSL
d08433	MMSL
721997002	SNOMEDCT_US
763543000	SNOMEDCT_US
016844	NDDF
016845	NDDF
C510793	MESH_SUPPLEMENTAL_RECORD_UI
706782-28-7	SECONDARY_CAS_RN

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
NUPLAZID	HUMAN PRESCRIPTION DRUG LABEL	1	63090-100	TABLET, COATED	10 mg	ORAL	NDA	32 sections
NUPLAZID	HUMAN PRESCRIPTION DRUG LABEL	1	63090-170	TABLET, COATED	17 mg	ORAL	NDA	32 sections
NUPLAZID	HUMAN PRESCRIPTION DRUG LABEL	1	63090-340	CAPSULE	34 mg	ORAL	NDA	32 sections