Tag «fda 2018»

Tagraxofusp タグラクソフスプ

It’s only fair to share… MGADDVVDSS KSFVMENFSS YHGTKPGYVD SIQKGIQKPK SGTQGNYDDD WKGFYSTDNK YDAAGYSVDN ENPLSGKAGG VVKVTYPGLT KVLALKVDNA ETIKKELGLS LTEPLMEQVG TEEFIKRFGD GASRVVLSLP FAEGSSSVEY INNWEQAKAL SVELEINFET RGKRGQDAMY EYMAQACAGN RVRRSVGSSL SCINLDWDVI RDKTKTKIES LKEHGPIKNK MSESPNKTVS EEKAKQYLEE FHQTALEHPE LSELKTVTGT NPVFAGANYA AWAVNVAQVI DSETADNLEK TTAALSILPG IGSVMGIADG AVHHNTEEIV AQSIALSSLM VAQAIPLVGE LVDIGFAAYN FVESIINLFQ VVHNSYNRPA YSPGHKTRPH MAPMTQTTSL KTSWVNCSNM IDEIITHLKQ PPLPLLDFNN LNGEDQDILM ENNLRRPNLE AFNRAVKSLQ NASAIESILK NLLPCLPLAT AAPTRHPIHI KDGDWNEFRR …

Omadacycline tosylate

It’s only fair to share… Omadacycline tosylate 728.8521, C29H40N4O7. C7H8O3S CAS: 1075240-43-5 389139-89-3 FREE FORM FDA 2018/10/3, Nuzyra オマダサイクリントシル酸塩; UNII-5658Y89YCD (4S,4aS,5aR,12aS)-4,7-Bis(dimethylamino)-9-{[(2,2-dimethylpropyl)amino]methyl}-3,10,12,12a-tetrahydroxy-1,11-dioxo-1,4,4a,5,5a,6,11,12a-octahydro-2-tetracenecarboxamide 4-methylbenzenesulfonate (1:1) 1075240-43-5 [RN] 2-Naphthacenecarboxamide, 4,7-bis(dimethylamino)-9-[[(2,2-dimethylpropyl)amino]methyl]-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-, (4S,4aS,5aR,12aS)-, 4-methylbenzenesulfonate (1:1) (salt) 5658Y89YCD Amadacycline tosylate PTK 0796 / PTK-0796 Omadacycline FREE FORM, 389139-89-3 FREE FORM Omadacycline has been used in trials studying the treatment of Bacterial Pneumonia, Bacterial Infections, Community-Acquired Infections, and Skin Structures and …

FDA approves first treatment Gamifant (emapalumab) specifically for patients with rare and life-threatening type of immune disease

It’s only fair to share… FDA approves first treatment Gamifant (emapalumab)  specifically for patients with rare and life-threatening type of immune disease  The U.S. Food and Drug Administration today approved Gamifant (emapalumab) for the treatment of pediatric (newborn and above) and adult patients with primary hemophagocytic lymphohistiocytosis (HLH) who have refractory, recurrent or progressive disease …

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 …

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 …

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 …