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odevixibat 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| ileal bile acid transporter (IBAT) inhibitors, bile acid reabsorption inhibitors | 5468 | 501692-44-0 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Odevixibat is a reversible inhibitor of the ileal bile acid transporter (IBAT). It decreases the reabsorption of bile acids (primarily the salt forms) from the terminal ileum. Pruritus is a common symptom in patients with PFIC and the pathophysiology of pruritus in patients with PFIC is not completely understood. Although the complete mechanism by which odevixibat improves pruritus in PFIC patients is unknown, it may involve inhibition of the IBAT, which results in decreased reuptake of bile salts, as observed by a decrease in serum bile acids.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
None
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| azlogd74 | LogD at pH 7.4 | 3.715 | High | 1 | |
| caco2-efflux | Caco-2 efflux ratio (BA/AB) | 250.611 | High | 1 | |
| caco2-intrinsic-papp | Caco-2 intrinsic apparent permeability | 0.459 | 10^-6 cm/s | High | 1 |
| dh-clint | Dog hepatocyte intrinsic clearance | 10.069 | uL/min/10^6 cells | High | 1 |
| dppb | Dog plasma protein binding (% unbound) | 0.110 | % | High | 1 |
| fcs-ppb | Fetal calf serum protein binding (% unbound) | 0.190 | % | High | 1 |
| herg | hERG pIC50 | 4.483 | pIC50 | High | 1 |
| hh-clint | Human hepatocyte intrinsic clearance | 15.382 | uL/min/10^6 cells | High | 1 |
| hlm-clint | Human liver microsomal intrinsic clearance | 21.627 | uL/min/mg protein | High | 1 |
| hppb | Human plasma protein binding (% unbound) | 0.410 | % | High | 1 |
| kinase-safety-class | ACVR2A,ACVR2B,AURKA,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK5,CDK9,DYRK1B,EGFR,EIF2AK3,EPHB4,ERBB2,GRK2,ITK,MAP2K6,MAP3K7,MAPK14,MAPK7,MAPKAPK2,NTRK2,PDK1,PDK2,PDK4,PIK3CB,PIK3CD,PIK3CG,PRKDC,STK33,TEK,TGFBR1,ZAP70 | 34 | |||
| kinase-selectivity-class | AXL,GRK2,MAP2K6,TEK | 4 | |||
| mdck-mdr1-efflux | MDCK-MDR1 efflux ratio | 18.793 | High | 1 | |
| mh-clint | Mouse hepatocyte intrinsic clearance | 11.967 | High | 1 | |
| mppb | Mouse plasma protein binding (% unbound) | 0.110 | High | 1 | |
| nih-mdck-mdr1-efflux | NIH MDCK-MDR1 efflux ratio | 30.130 | High | 1 | |
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 | |||
| pppb | Pig plasma protein binding (% unbound) | 0.200 | % | High | 1 |
| rh-clint | Rat hepatocyte intrinsic clearance | 8.690 | uL/min/10^6 cells | High | 1 |
| rh-fuinc | Rat hepatocyte fraction unbound in incubation | 0.530 | % | High | 1 |
| rppb | Rat plasma protein binding (% unbound) | 0.150 | % | High | 1 |
| solubility-dd | Solubility at pH 7.4 in DMSO | 75.509 | uM | High | 1 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| July 20, 2021 | FDA | ALBIREO PHARMA INC | |
| July 16, 2021 | EMA | ALBIREO |
FDA Adverse Event Reporting System (Female)
None
FDA Adverse Event Reporting System (Male)
None
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 |
|---|---|---|---|---|---|---|
| Liver transplant | 65.19 | 55.35 | 11 | 255 | 4578 | 110584455 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | A05AX05 | ALIMENTARY TRACT AND METABOLISM BILE AND LIVER THERAPY BILE THERAPY Other drugs for bile therapy |
| FDA EPC | N0000193957 | Ileal Bile Acid Transporter Inhibitor |
| FDA MoA | N0000193958 | Ileal Bile Acid Transporter Inhibitors |
Related Drugs by ATC class:
A05AX Other drugs for bile therapy 6 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Pruritus in progressive familial intrahepatic cholestasis (PFIC) | indication | 74162007 | DOID:0070221 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
None
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 |
|---|---|---|---|---|---|---|---|---|---|---|
| 0.2MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE, PELLETS | ORAL | 10011633 | Nov. 8, 2031 | METHOD OF TREATING CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS) |
| 0.2MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE, PELLETS | ORAL | 10011633 | Nov. 8, 2031 | METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) |
| 0.2MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE, PELLETS | ORAL | 10093697 | Nov. 8, 2031 | METHOD OF TREATING CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS) |
| 0.2MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE, PELLETS | ORAL | 10093697 | Nov. 8, 2031 | METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) |
| 0.2MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE, PELLETS | ORAL | 10487111 | Nov. 8, 2031 | METHOD OF TREATING CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS) |
| 0.2MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE, PELLETS | ORAL | 10487111 | Nov. 8, 2031 | METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) |
| 0.2MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE, PELLETS | ORAL | 10981952 | Nov. 8, 2031 | METHOD OF REDUCING SERUM BILE ACIDS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS) |
| 0.2MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE, PELLETS | ORAL | 10981952 | Nov. 8, 2031 | METHOD OF REDUCING SERUM BILE ACIDS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) |
| 0.2MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE, PELLETS | ORAL | 10981952 | Nov. 8, 2031 | METHOD OF TREATING CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS) |
| 0.2MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE, PELLETS | ORAL | 10981952 | Nov. 8, 2031 | METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) |
| 0.2MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE, PELLETS | ORAL | 11732006 | Nov. 8, 2031 | METHOD OF TREATING CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS) |
| 0.2MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE, PELLETS | ORAL | 11732006 | Nov. 8, 2031 | METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) |
| 0.2MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE, PELLETS | ORAL | 12187812 | Nov. 8, 2031 | METHOD OF TREATING CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS) |
| 0.2MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE, PELLETS | ORAL | 12187812 | Nov. 8, 2031 | METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) |
| 0.2MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE, PELLETS | ORAL | 12545705 | Nov. 8, 2031 | METHOD OF TREATING CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS) |
| 0.2MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE, PELLETS | ORAL | 12545705 | Nov. 8, 2031 | METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) |
| 0.4MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE | ORAL | 10011633 | Nov. 8, 2031 | METHOD OF TREATING CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS) |
| 0.4MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE | ORAL | 10011633 | Nov. 8, 2031 | METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) |
| 0.4MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE | ORAL | 10093697 | Nov. 8, 2031 | METHOD OF TREATING CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS) |
| 0.4MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE | ORAL | 10093697 | Nov. 8, 2031 | METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) |
| 0.4MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE | ORAL | 10487111 | Nov. 8, 2031 | METHOD OF TREATING CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS) |
| 0.4MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE | ORAL | 10487111 | Nov. 8, 2031 | METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) |
| 0.4MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE | ORAL | 10981952 | Nov. 8, 2031 | METHOD OF REDUCING SERUM BILE ACIDS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS) |
| 0.4MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE | ORAL | 10981952 | Nov. 8, 2031 | METHOD OF REDUCING SERUM BILE ACIDS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) |
| 0.4MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE | ORAL | 10981952 | Nov. 8, 2031 | METHOD OF TREATING CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS) |
| 0.4MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE | ORAL | 10981952 | Nov. 8, 2031 | METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) |
| 0.4MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE | ORAL | 11732006 | Nov. 8, 2031 | METHOD OF TREATING CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS) |
| 0.4MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE | ORAL | 11732006 | Nov. 8, 2031 | METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) |
| 0.4MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE | ORAL | 12187812 | Nov. 8, 2031 | METHOD OF TREATING CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS) |
| 0.4MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE | ORAL | 12187812 | Nov. 8, 2031 | METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) |
| 0.4MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE | ORAL | 12545705 | Nov. 8, 2031 | METHOD OF TREATING CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS) |
| 0.4MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE | ORAL | 12545705 | Nov. 8, 2031 | METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) |
| 0.6MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE, PELLETS | ORAL | 10011633 | Nov. 8, 2031 | METHOD OF TREATING CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS) |
| 0.6MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE, PELLETS | ORAL | 10011633 | Nov. 8, 2031 | METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) |
| 0.6MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE, PELLETS | ORAL | 10093697 | Nov. 8, 2031 | METHOD OF TREATING CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS) |
| 0.6MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE, PELLETS | ORAL | 10093697 | Nov. 8, 2031 | METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) |
| 0.6MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE, PELLETS | ORAL | 10487111 | Nov. 8, 2031 | METHOD OF TREATING CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS) |
| 0.6MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE, PELLETS | ORAL | 10487111 | Nov. 8, 2031 | METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) |
| 0.6MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE, PELLETS | ORAL | 10981952 | Nov. 8, 2031 | METHOD OF REDUCING SERUM BILE ACIDS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS) |
| 0.6MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE, PELLETS | ORAL | 10981952 | Nov. 8, 2031 | METHOD OF REDUCING SERUM BILE ACIDS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) |
| 0.6MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE, PELLETS | ORAL | 10981952 | Nov. 8, 2031 | METHOD OF TREATING CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS) |
| 0.6MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE, PELLETS | ORAL | 10981952 | Nov. 8, 2031 | METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) |
| 0.6MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE, PELLETS | ORAL | 11732006 | Nov. 8, 2031 | METHOD OF TREATING CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS) |
| 0.6MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE, PELLETS | ORAL | 11732006 | Nov. 8, 2031 | METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) |
| 0.6MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE, PELLETS | ORAL | 12187812 | Nov. 8, 2031 | METHOD OF TREATING CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS) |
| 0.6MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE, PELLETS | ORAL | 12187812 | Nov. 8, 2031 | METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) |
| 0.6MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE, PELLETS | ORAL | 12545705 | Nov. 8, 2031 | METHOD OF TREATING CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS) |
| 0.6MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE, PELLETS | ORAL | 12545705 | Nov. 8, 2031 | METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) |
| 1.2MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE | ORAL | 10011633 | Nov. 8, 2031 | METHOD OF TREATING CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS) |
| 1.2MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE | ORAL | 10011633 | Nov. 8, 2031 | METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) |
| 1.2MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE | ORAL | 10093697 | Nov. 8, 2031 | METHOD OF TREATING CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS) |
| 1.2MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE | ORAL | 10093697 | Nov. 8, 2031 | METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) |
| 1.2MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE | ORAL | 10487111 | Nov. 8, 2031 | METHOD OF TREATING CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS) |
| 1.2MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE | ORAL | 10487111 | Nov. 8, 2031 | METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) |
| 1.2MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE | ORAL | 10981952 | Nov. 8, 2031 | METHOD OF REDUCING SERUM BILE ACIDS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS) |
| 1.2MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE | ORAL | 10981952 | Nov. 8, 2031 | METHOD OF REDUCING SERUM BILE ACIDS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) |
| 1.2MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE | ORAL | 10981952 | Nov. 8, 2031 | METHOD OF TREATING CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS) |
| 1.2MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE | ORAL | 10981952 | Nov. 8, 2031 | METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) |
| 1.2MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE | ORAL | 11732006 | Nov. 8, 2031 | METHOD OF TREATING CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS) |
| 1.2MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE | ORAL | 11732006 | Nov. 8, 2031 | METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) |
| 1.2MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE | ORAL | 12187812 | Nov. 8, 2031 | METHOD OF TREATING CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS) |
| 1.2MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE | ORAL | 12187812 | Nov. 8, 2031 | METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) |
| 1.2MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE | ORAL | 12545705 | Nov. 8, 2031 | METHOD OF TREATING CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS) |
| 1.2MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE | ORAL | 12545705 | Nov. 8, 2031 | METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) |
| 0.2MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE, PELLETS | ORAL | 9694018 | March 18, 2034 | METHOD OF TREATING CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS) |
| 0.2MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE, PELLETS | ORAL | 9694018 | March 18, 2034 | METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) |
| 0.4MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE | ORAL | 9694018 | March 18, 2034 | METHOD OF TREATING CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS) |
| 0.4MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE | ORAL | 9694018 | March 18, 2034 | METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) |
| 0.6MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE, PELLETS | ORAL | 9694018 | March 18, 2034 | METHOD OF TREATING CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS) |
| 0.6MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE, PELLETS | ORAL | 9694018 | March 18, 2034 | METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) |
| 1.2MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE | ORAL | 9694018 | March 18, 2034 | METHOD OF TREATING CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS) |
| 1.2MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE | ORAL | 9694018 | March 18, 2034 | METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) |
| 0.2MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE, PELLETS | ORAL | 11365182 | June 20, 2039 | METHOD OF TREATING CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS) |
| 0.2MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE, PELLETS | ORAL | 11365182 | June 20, 2039 | METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) |
| 0.2MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE, PELLETS | ORAL | 12508234 | June 20, 2039 | METHOD OF TREATING CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS) |
| 0.2MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE, PELLETS | ORAL | 12508234 | June 20, 2039 | METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) |
| 0.4MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE | ORAL | 11365182 | June 20, 2039 | METHOD OF TREATING CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS) |
| 0.4MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE | ORAL | 11365182 | June 20, 2039 | METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) |
| 0.4MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE | ORAL | 12508234 | June 20, 2039 | METHOD OF TREATING CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS) |
| 0.4MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE | ORAL | 12508234 | June 20, 2039 | METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) |
| 0.6MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE, PELLETS | ORAL | 11365182 | June 20, 2039 | METHOD OF TREATING CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS) |
| 0.6MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE, PELLETS | ORAL | 11365182 | June 20, 2039 | METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) |
| 0.6MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE, PELLETS | ORAL | 12508234 | June 20, 2039 | METHOD OF TREATING CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS) |
| 0.6MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE, PELLETS | ORAL | 12508234 | June 20, 2039 | METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) |
| 1.2MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE | ORAL | 11365182 | June 20, 2039 | METHOD OF TREATING CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS) |
| 1.2MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE | ORAL | 11365182 | June 20, 2039 | METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) |
| 1.2MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE | ORAL | 12508234 | June 20, 2039 | METHOD OF TREATING CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS) |
| 1.2MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE | ORAL | 12508234 | June 20, 2039 | METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) |
| 0.2MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE, PELLETS | ORAL | 11583539 | Nov. 12, 2041 | METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) |
| 0.2MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE, PELLETS | ORAL | 12447156 | Nov. 12, 2041 | METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) |
| 0.4MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE | ORAL | 11583539 | Nov. 12, 2041 | METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) |
| 0.4MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE | ORAL | 12447156 | Nov. 12, 2041 | METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) |
| 0.6MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE, PELLETS | ORAL | 11583539 | Nov. 12, 2041 | METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) |
| 0.6MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE, PELLETS | ORAL | 12447156 | Nov. 12, 2041 | METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) |
| 1.2MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE | ORAL | 11583539 | Nov. 12, 2041 | METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) |
| 1.2MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE | ORAL | 12447156 | Nov. 12, 2041 | METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 0.2MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE, PELLETS | ORAL | June 13, 2026 | TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OF AGE AND OLDER WITH ALAGILLE SYNDROME (ALGS) |
| 0.4MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE | ORAL | June 13, 2026 | TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OF AGE AND OLDER WITH ALAGILLE SYNDROME (ALGS) |
| 0.6MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE, PELLETS | ORAL | June 13, 2026 | TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OF AGE AND OLDER WITH ALAGILLE SYNDROME (ALGS) |
| 1.2MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE | ORAL | June 13, 2026 | TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OF AGE AND OLDER WITH ALAGILLE SYNDROME (ALGS) |
| 0.2MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE, PELLETS | ORAL | July 20, 2026 | NEW CHEMICAL ENTITY |
| 0.4MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE | ORAL | July 20, 2026 | NEW CHEMICAL ENTITY |
| 0.6MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE, PELLETS | ORAL | July 20, 2026 | NEW CHEMICAL ENTITY |
| 1.2MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE | ORAL | July 20, 2026 | NEW CHEMICAL ENTITY |
| 0.2MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE, PELLETS | ORAL | July 20, 2028 | TREATMENT OF PRURITUS IN PATIENTS 3 MONTHS OF AGE AND OLDER WITH PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) |
| 0.4MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE | ORAL | July 20, 2028 | TREATMENT OF PRURITUS IN PATIENTS 3 MONTHS OF AGE AND OLDER WITH PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) |
| 0.6MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE, PELLETS | ORAL | July 20, 2028 | TREATMENT OF PRURITUS IN PATIENTS 3 MONTHS OF AGE AND OLDER WITH PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) |
| 1.2MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE | ORAL | July 20, 2028 | TREATMENT OF PRURITUS IN PATIENTS 3 MONTHS OF AGE AND OLDER WITH PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) |
| 0.2MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE, PELLETS | ORAL | June 13, 2030 | TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OF AGE AND OLDER WITH ALAGILLE SYNDROME (ALGS) |
| 0.4MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE | ORAL | June 13, 2030 | TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OF AGE AND OLDER WITH ALAGILLE SYNDROME (ALGS) |
| 0.6MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE, PELLETS | ORAL | June 13, 2030 | TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OF AGE AND OLDER WITH ALAGILLE SYNDROME (ALGS) |
| 1.2MG | BYLVAY | IPSEN | N215498 | July 20, 2021 | RX | CAPSULE | ORAL | June 13, 2030 | TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OF AGE AND OLDER WITH ALAGILLE SYNDROME (ALGS) |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Ileal sodium/bile acid cotransporter | Transporter | INHIBITOR | IC50 | 9.89 | DRUG LABEL | DRUG LABEL | |||
| Bile acid receptor | Nuclear hormone receptor | IC50 | 9.80 | CHEMBL |
External reference:
| ID | Source |
|---|---|
| 2W150K0UUC | UNII |
| C5238052 | UMLSCUI |
| CHEBI:757063 | CHEBI |
| CHEMBL4297588 | ChEMBL_ID |
| D11716 | KEGG_DRUG |
| 10153627 | PUBCHEM_CID |
| DB16261 | DRUGBANK_ID |
| CHEMBL5315120 | ChEMBL_ID |
| 10706 | INN_ID |
| C000713258 | MESH_SUPPLEMENTAL_RECORD_UI |
| 11194 | IUPHAR_LIGAND_ID |
| 1179270000 | SNOMEDCT_US |
| 1179274009 | SNOMEDCT_US |
| 4040726 | VANDF |
| 348576 | MMSL |
| 39722 | MMSL |
| d09775 | MMSL |
| 018812 | NDDF |
| 2563966 | RXNORM |
| 2W150K0UUC | INXIGHT DRUGS |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Bylvay | HUMAN PRESCRIPTION DRUG LABEL | 1 | 15054-3301 | CAPSULE, COATED PELLETS | 200 ug | ORAL | NDA | 31 sections |
| Bylvay | HUMAN PRESCRIPTION DRUG LABEL | 1 | 15054-3302 | CAPSULE | 400 ug | ORAL | NDA | 31 sections |
| Bylvay | HUMAN PRESCRIPTION DRUG LABEL | 1 | 15054-3303 | CAPSULE, COATED PELLETS | 600 ug | ORAL | NDA | 31 sections |
| Bylvay | HUMAN PRESCRIPTION DRUG LABEL | 1 | 15054-3304 | CAPSULE | 1200 ug | ORAL | NDA | 31 sections |
| BYLVAY | HUMAN PRESCRIPTION DRUG LABEL | 1 | 74528-020 | CAPSULE, COATED PELLETS | 200 ug | ORAL | NDA | 31 sections |
| BYLVAY | HUMAN PRESCRIPTION DRUG LABEL | 1 | 74528-040 | CAPSULE, COATED PELLETS | 400 ug | ORAL | NDA | 31 sections |
| BYLVAY | HUMAN PRESCRIPTION DRUG LABEL | 1 | 74528-060 | CAPSULE, COATED PELLETS | 600 ug | ORAL | NDA | 31 sections |
| BYLVAY | HUMAN PRESCRIPTION DRUG LABEL | 1 | 74528-120 | CAPSULE, COATED PELLETS | 1200 ug | ORAL | NDA | 31 sections |