e-Drug3D

1453

cas 106308-44-5

CLASS

NERVOUS SYSTEM
ANTIEPILEPTIC
PROLONGATION OF THE INACTIVE STATE OF THE CHANNEL
INHIBITOR

ROUTE (list)

ORAL

PK parameters

F 85 PERCENT (600 MILLIGRAM)
Tmax 5 HOUR
VD 50 LITER (3200 MILLIGRAM / DAY)
Cl 4.3 LITER / HOUR (EQN)
PPB 34 PERCENT
t1/2 8 HOUR

MW 238.20
NB_atoms 17
XLogP 0.70
PSA 71.743
NB_HD 2
NB_HA 5
fsp3 0.10
Lipinski(0=no;1=yes) 1

FDA
NDA 021911 (label) INN (RUFINAMIDE) BANZEL (EISAI INC) APPROVAL= AP YEAR= 2008 NEWMOLECULARENTITY
NDA 201367 (label) INN (RUFINAMIDE) BANZEL (EISAI INC) APPROVAL= AP YEAR= 2011
NDA 204988 (label) INN (RUFINAMIDE) RUFINAMIDE (HIKMA) APPROVAL= AP YEAR= 2016
NDA 205075 (label) INN (RUFINAMIDE) RUFINAMIDE (GLENMARK PHARMS LTD) APPROVAL= AP YEAR= 2016
NDA 205095 (label) INN (RUFINAMIDE) RUFINAMIDE (PHARMOBEDIENT) APPROVAL= AP YEAR= 2016
NDA 207363 (pdf not found) INN (RUFINAMIDE) RUFINAMIDE (HIKMA) APPROVAL= AP YEAR= 2019
NDA 211388 (pdf not found) INN (RUFINAMIDE) RUFINAMIDE (BIONPHARMA) APPROVAL= AP YEAR= 2019
NDA 213457 (pdf not found) INN (RUFINAMIDE) RUFINAMIDE (LUPIN LTD) APPROVAL= AP YEAR= 2020
NDA 204993 (pdf not found) INN (RUFINAMIDE) RUFINAMIDE (HETERO LABS LTD III) APPROVAL= AP YEAR= 2021
NDA 213410 (pdf not found) INN (RUFINAMIDE) RUFINAMIDE (ALKEM LABS LTD) APPROVAL= AP YEAR= 2021
NDA 214009 (pdf not found) INN (RUFINAMIDE) RUFINAMIDE (CHARTWELL RX) APPROVAL= AP YEAR= 2022
NDA 204964 (pdf not found) INN (RUFINAMIDE) RUFINAMIDE (LUPIN LTD) APPROVAL= AP YEAR= 2022
NDA 216549 (pdf not found) INN (RUFINAMIDE) RUFINAMIDE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2022
NDA 216688 (pdf not found) INN (RUFINAMIDE) RUFINAMIDE (MICRO LABS) APPROVAL= AP YEAR= 2023
NDA 217230 (pdf not found) INN (RUFINAMIDE) RUFINAMIDE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2023
NDA 216841 (pdf not found) INN (RUFINAMIDE) RUFINAMIDE (HETERO LABS LTD III) APPROVAL= AP YEAR= 2023
NDA 214817 (pdf not found) INN (RUFINAMIDE) RUFINAMIDE (MSN) APPROVAL= AP YEAR= 2025