Category «fda 2018»

USFDA approval to Lumoxiti (moxetumomab pasudotoxtdfk) a new treatment for hairy cell leukemia

It’s only fair to share… USFDA approval to Lumoxiti is a new treatment for hairy cell leukemia On September 13, 2018, the U.S. Food and Drug Administration approved Lumoxiti (moxetumomab pasudotoxtdfk) injection for intravenous use for the treatment of adult patients with relapsed or refractory Hairy Cell Leukemia (HCL) who have received at least two …

Sarecycline , サレサイクリン

It’s only fair to share…   Sarecycline サレサイクリン MW 487.5024, MF C24H29N3O8 FREE FORM Paratek  INNOVATOR FDA 2018/10/1 APPROVED SEYSARA, ALMIRALL, for the oral treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older (4S,4aS,5aR,12aS)-4-(dimethylamino)-3,10,12,12a-tetrahydroxy-7-[(methoxymethylamino)methyl]-1,11-dioxo-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-carboxamide (4S,4aS,5aR,12aS)-4-(Dimethylamino)-3,10,12,12a-tetrahydroxy-7-{[methoxy(methyl)amino]methyl}-1,11-dioxo-1,4,4a,5,5a,6,11,12a-octahydro-2-tetracenecarboxamide 1035654-66-0 [RN] FREE FORM 2-Naphthacenecarboxamide, 4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-7-[(methoxymethylamino)methyl]-1,11-dioxo-, (4S,4aS,5aR,12aS)- 94O110CX2E 9743 P005672,  P 005672 CAS 1035979-44-2 HCl Molecular …

Glycopyrrolate Tosylate

It’s only fair to share…   Glycopyrrolate Tosylate Molecular Formula: C26H35NO6S Molecular Weight: 489.627 g/mol (1,1-dimethylpyrrolidin-1-ium-3-yl) 2-cyclopentyl-2-hydroxy-2-phenylacetate;4-methylbenzenesulfonate CAS 873295-46-6 , C19 H28 N O3 . C7 H7 O3 S, Pyrrolidinium, 3-[(2-cyclopentyl-2-hydroxy-2-phenylacetyl)oxy]-1,1-dimethyl-, 4-methylbenzenesulfonate (1:1) Glycopyrronium tosylate monohydrate Molecular Formula, C19-H28-N-O3.C7-H8-O3-S.H2-O, Molecular Weight, 508.6522 https://chem.nlm.nih.gov/chemidplus/structure/1624259-25-1?maxscale=30&width=300&height=300 CAS 1624259-25-1, C19 H28 N O3 . C7 H7 O3 S . H2 O, Pyrrolidinium, 3-[(2-cyclopentyl-2-hydroxy-2-phenylacetyl)oxy]-1,1-dimethyl-, 4-methylbenzenesulfonate, hydrate (1:1:1) Dermira (Originator) DRM-04 DRM-04B   DRM-04 tosylate monohydrate DRM04 DRM04 …

Lanadelumab, ラナデルマブ

It’s only fair to share…   (Heavy chain) EVQLLESGGG LVQPGGSLRL SCAASGFTFS HYIMMWVRQA PGKGLEWVSG IYSSGGITVY ADSVKGRFTI SRDNSKNTLY LQMNSLRAED TAVYYCAYRR IGVPRRDEFD IWGQGTMVTV SSASTKGPSV FPLAPSSKST SGGTAALGCL VKDYFPEPVT VSWNSGALTS GVHTFPAVLQ SSGLYSLSSV VTVPSSSLGT QTYICNVNHK PSNTKVDKRV EPKSCDKTHT CPPCPAPELL GGPSVFLFPP KPKDTLMISR TPEVTCVVVD VSHEDPEVKF NWYVDGVEVH NAKTKPREEQ YNSTYRVVSV LTVLHQDWLN GKEYKCKVSN KALPAPIEKT ISKAKGQPRE PQVYTLPPSR EEMTKNQVSL TCLVKGFYPS DIAVEWESNG QPENNYKTTP PVLDSDGSFF LYSKLTVDKS RWQQGNVFSC SVMHEALHNH YTQKSLSLSP G (Light …

Sodium zirconium cyclosilicate, ナトリウムジルコニウムシクロケイ酸塩

It’s only fair to share… Sodium zirconium cyclosilicate ZS-9, ZS 9, UZSi-9 CAS 242800-27-7, H2 O3 Si . x H2 O . 2/3 Na . 1/3 Zr, Sodium zirconium cyclosilicate; Silicic acid (H2SiO3), Sodium zirconium(4+) salt (3:2:1), hydrate USAN CAS 17141-74-1, H6 O9 Si3 . 2 Na . Zr, Silicic acid (H2SiO3), sodium zirconium(4+) salt (3:2:1), hydrate, Sodium zirconium silicate (Na2ZrSi3O9) hydrate ナトリウムジルコニウムシクロケイ酸塩 ZrH4O6. 3H4SiO4. 2H2O. 2Na, 561.6068, AS IN kegg …

Stiripentol, スチリペントール

It’s only fair to share… Stiripentol スチリペントール STIRIPENTOL; Diacomit; 49763-96-4; BCX 2600; Estiripentol; Stiripentolum CAS: 137767-55-6 49763-96-4 (E)-1-(1,3-benzodioxol-5-yl)-4,4-dimethylpent-1-en-3-ol Molecular Formula: C14H18O3 Molecular Weight: 234.295 g/mol UNII R02XOT8V8I, Diacomit fda approval 2018/8/20 Stiripentol (marketed as Diacomit by Laboratoires Biocodex) is an anticonvulsant drug used in the treatment of epilepsy. It is approved for the treatment of Dravet syndrome, an epilepsy syndrome. It is unrelated to other …

Plazomicin sulfate, プラゾマイシン硫酸塩 ,

It’s only fair to share… Plazomicin Molecular FormulaC25H48N6O10 Average mass592.683 Da (2S)-4-Amino-N-[(1R,2S,3S,4R,5S)-5-amino-4-{[(2S,3R)-3-amino-6-{[(2-hydroxyéthyl)amino]méthyl}-3,4-dihydro-2H-pyran-2-yl]oxy}-2-{[3-désoxy-4-C-méthyl-3-(méthylamino)-β-L-arabinopyranosyl]oxy}-3-hyd roxycyclohexyl]-2-hydroxybutanamide [French][ACD/IUPAC Name] 1154757-24-0 [RN] 9522 ACHN-490 Plazomicin Sulfate Molecular Formula: C25H50N6O14S Molecular Weight: 690.763 g/mol Plazomicin Sulfate; UNII-A78L6MT746; Plazomicin Sulfate [USAN]; A78L6MT746; 1380078-95-4; Plazomicin sulfate (USAN), ACHN 490 sulfate 6′-(hydroxylethyl)-1-(haba)-sisomicin Plazomicin is a neoglycoside antibiotic with activity against a broad range of Gram-positive and Gram-negive …

BINIMETINIB, биниметиниб , بينيميتينيب , 美替尼 , ビニメチニブ

It’s only fair to share… Binimetinib MEK-162 биниметиниб [Russian] [INN] بينيميتينيب [Arabic] [INN] 贝美替尼 [Chinese] [INN] ビニメチニブ 5-[(4-bromo-2-fluorophenyl)amino]-4-fluoro-N-(2-hydroxyethoxy)-1-methyl-1H-benzimidazole-6-carboxamide 5-(4-Bromo-2-fluorophenylamino)-4-fluoro-1-methyl-1H-benzimidazole-6-carbohydroxamic acid 2-hydroxyethyl ester 6-(4-Bromo-2-fluorophenylamino)-7-fluoro-3-methyl-3H-benzoimidazole-5-carboxylic acid (2-hydroxyethyoxy)-amide 606143-89-9  CAS C17H15BrF2N4O3, 441.227 UNII-181R97MR71 181R97MR71 1H-Benzimidazole-6-carboxamide, 5-[(4-bromo-2-fluorophenyl)amino]-4-fluoro-N-(2-hydroxyethoxy)-1-methyl- STR……….http://www.who.int/medicines/publications/druginformation/innlists/PL109.pdf                                 GET THE STRUCTURE tyrosine kinase inhibitor, antineoplastic Array BioPharma Inc;PHASE 3 Cancer, ovary (serous) Novartis PHASE 3 Melanoma CAS 606143-89-9 [RN] 9764 ARRY-162 ARRY-438162, NVP-MEK162 MEK-1 protein kinase inhibitor; …

FDA approves first drug Oxervate (cenegermin) for neurotrophic keratitis, a rare eye disease

It’s only fair to share… http://www.who.int/medicines/publications/druginformation/issues/77_INN_Recommended_List.pdf Active Substance General information The active substance in Oxervate, cenegermin, is a recombinant human Nerve Growth factor (rhNGF) produced in E. coli strain HMS174. The molecule is identical to human Nerve Growth factor (NGF), a naturally occurring human protein. In humans, NGF is naturally produced as pre-pro-peptide, secreted into …

Patisiran

It’s only fair to share… Patisiran Sense strand: GUAACCAAGAGUAUUCCAUdTdT Anti-sense strand: AUGGAAUACUCUUGGUUACdTdT RNA, (A-U-G-G-A-A-Um-A-C-U-C-U-U-G-G-U-Um-A-C-dT-dT), complex with RNA (G-Um-A-A-Cm-Cm-A-A-G-A-G-Um-A-Um-Um-Cm-Cm-A-Um-dT-dT) (1:1), ALN-18328, 6024128  , ALN-TTR02  , GENZ-438027  , SAR-438037  , 50FKX8CB2Y (UNII code)  for RNA, (A-U-G-G-A-A-Um-A-C-U-C-U-U-G-G-U-Um-A-C-dT-dT), complex with RNA(G-Um-A-A-Cm-Cm-A-A-G-A-G-Um-A-Um-Um-Cm-Cm-A-Um-dT-dT) (1:1) Nucleic Acid Sequence Sequence Length: 42, 21, 2112 a 7 c 7 g 4 t 12 umultistranded (2); modified CAS 1420706-45-1 Treatment of Amyloidosis, …