Category «FDA 2019»

Fam-trastuzumab deruxtecan-nxki

It’s only fair to share… Fam-trastuzumab deruxtecan-nxki Formula C6460H9972N1724O2014S44. (C52H57FN9O13)8 CAS 1826843-81-5 Mol weight 153701.9811 Antineoplastic   Disease Breast cancer (HER2 positive) DS-8201a Trastuzumab deruxtecan, sold under the brand name Enhertu, is an antibody-drug conjugate consisting of the humanized monoclonal antibody trastuzumab (Herceptin) covalently linked to the topoisomerase I inhibitor deruxtecan (a derivative of exatecan).[5][6] It is licensed for the treatment of breast cancer or gastric or gastroesophageal adenocarcinoma.[6][7] Trastuzumab binds to and …

TRIFAROTENE

It’s only fair to share… Trifarotene CAS 895542-09-3 3”-Tert-butyl-4′-(2-hydroxyethoxy)-4”-(pyrrolidin-1-yl)(1,1′:3′,1”)terphenyl-4-carboxylic acid 3′-[3-tert-butyl-4-(pyrrolidin-1-yl)phenyl]-4′-(2-hydroxyethoxy)-[1,1′-biphenyl]-4-carboxylic acid [1,1′:3′,1”-Terphenyl]-4-carboxylic acid, 3”-(1,1-dimethylethyl)-4′-(2-hydroxyethoxy)-4”-(1-pyrrolidinyl)- 0J8RN2W0HK 4′-(2-Hydroxyethoxy)-3”-(2-methyl-2-propanyl)-4”-(1-pyrrolidinyl)-1,1′:3′,1”-terphenyl-4-carboxylic acid UNII-0J8RN2W0HK, Galderma Research & Development 459.5766 C29 H33 N O4 CD-5789 CD5789 трифаротен [Russian] [INN] تريفاروتين [Arabic] [INN] 曲法罗汀 [Chinese] [INN] Trifarotene, sold under the brand name Aklief, is a medication for the topical treatment of acne vulgaris in those nine years of age and older.[1] It …

Zanubrutinib, ザヌブルチニブ , занубрутиниб , زانوبروتينيب ,

It’s only fair to share…   Zanubrutinib, BGB-3111 Formula C27H29N5O3 CAS 1691249-45-2 Mol weight 471.5509 FDA , 2019/11/14, Brukinsa ザヌブルチニブ , занубрутиниб [Russian] زانوبروتينيب [Arabic] (7S)-7-(1-Acryloyl-4-piperidinyl)-2-(4-phenoxyphenyl)-4,5,6,7-tetrahydropyrazolo[1,5-a]pyrimidine-3-carboxamide Pyrazolo[1,5-a]pyrimidine-3-carboxamide, 4,5,6,7-tetrahydro-7-[1-(1-oxo-2-propen-1-yl)-4-piperidinyl]-2-(4-phenoxyphenyl)-, (7S)- Antineoplastic, Bruton’s tyrosine kinase inhibitor, Mantle cell lymphoma Zanubrutinib, sold under the brand name Brukinsa, is for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.[3] …

Brilliant blue G , ブリリアントブルーG ,

It’s only fair to share…   Brilliant blue G FDA 2019, 12/20/2019, TISSUEBLUE, New Drug Application (NDA): 209569 Company: DUTCH OPHTHALMIC, PRIORITY; Orphan OPQ recommends APPROVAL of NDA 209569 for commercialization of TissueBlue (Brilliant Blue G Ophthalmic Solution), 0.025% Neuroprotectant sodium;3-[[4-[[4-(4-ethoxyanilino)phenyl]-[4-[ethyl-[(3-sulfonatophenyl)methyl]azaniumylidene]-2-methylcyclohexa-2,5-dien-1-ylidene]methyl]-N-ethyl-3-methylanilino]methyl]benzenesulfonate Formula C47H48N3O7S2. Na CAS 6104-58-1 Mol weight 854.0197 ブリリアントブルーG, C.I. Acid Blue 90 UNII-M1ZRX790SI M1ZRX790SI 6104-58-1 Brilliant Blue G Derma …

Fluorodopa F 18, フルオロドパ (18F), флуородопа (18F) , فلورودوبا (18F) , 氟[18F]多巴 ,

It’s only fair to share… Fluorodopa F 18 2019/10/10, fda 2019, Formula C9H10FNO4 Cas 92812-82-3 Mol weight 215.1784 Diagnostic aid (brain imaging), Radioactive agent, for use in positron emission tomography (PET) CAS 92812-82-3 フルオロドパ (18F) L-6-(18F)Fluoro-DOPA L-Tyrosine, 2-fluoro-18F-5-hydroxy- [ACD/Index Name] флуородопа (18F) [Russian] [INN] فلورودوبا (18F) [Arabic] [INN] 氟[18F]多巴 [Chinese] [INN] ((18)F)FDOPA 2-(fluoro-(18)F)-5-hydroxy-L-tyrosine 2-(Fluoro-18F)-5-hydroxy-L-tyrosine 2-(Fluoro-18F)-L-DOPA 2C598205QX 6-((18)F)fluoro-L-DOPA 6-(18F)Fluoro-L-DOPA 6692 (18F)FDOPA 2-((18)F)fluoro-5-hydroxy-L-tyrosine Fluorodopa, also …

Cefiderocol, セフィデロコル , цефидерокол , سيفيديروكول , 头孢德罗 ,

It’s only fair to share…   Cefiderocol セフィデロコル; Formula C30H34ClN7O10S2 CAS 1225208-94-5 Mol weight 752.2149 Antibacterial, Cell wall biosynthesis inhibitor, enicillin binding protein, Siderophore cephalosporin Fetroja (TN) FDA, Cefiderocol, APPROVED, 2019/11/14 (6R,7R)-7-{[(2Z)-2-(2-Amino-1,3-thiazol-4-yl)-2-{[(2-carboxy-2-propanyl)oxy]imino}acetyl]amino}-3-[(1-{2-[(2-chloro-3,4-dihydroxybenzoyl)amino]ethyl}-1-pyrrolidiniumyl)methyl]-8-oxo-5-thia-1-azabicycl o[4.2.0]oct-2-ene-2-carboxylate S-649266,  GSK 2696266D Cefiderocol, sold under the brand name Fetroja, is an antibiotic used to treat complicated urinary tract infections when no other options are available.[2] It is indicated for the treatment of multi-drug-resistant Gram-negative bacteria including Pseudomonas …

Givosiran, ギボシラン ,

It’s only fair to share… Givosiran N-[1,3-bis[3-[3-[5-[(2R,3R,4R,5R,6R)-3-acetamido-4,5-dihydroxy-6-(hydroxymethyl)oxan-2-yl]oxypentanoylamino]propylamino]-3-oxopropoxy]-2-[[3-[3-[5-[(2R,3R,4R,5R,6R)-3-acetamido-4,5-dihydroxy-6-(hydroxymethyl)oxan-2-yl]oxypentanoylamino]propylamino]-3-oxopropoxy]methyl]propan-2-yl]-12-[(2R,4R)-4-hydroxy-2-methylpyrrolidin-1-yl]-12-oxododecanamide Treatment of Acute Hepatic Porphyria (AHP) Formula C524H694F16N173O316P43S6 CAS  1639325-43-1 Mol weight 16300.3229 Treatment of acute hepatic porphyria, RNA interference (RNAi) drug FDA APPROVED, Givlaari, 2019/11/20 ギボシラン; RNA, (Cm-sp-Am-sp-Gm-Am-Am-Am-(2′-deoxy-2′-fluoro)G-Am-(2′-deoxy-2′-fluoro)G-Um-(2′-deoxy-2′-fluoro)G-Um-(2′-deoxy-2′-fluoro)C-Um-(2′-deoxy-2′-fluoro)C-Am-Um-Cm-Um-Um-Am), 3′-[[(2S,4R)-1-[29-[[2-(acetylamino)-2-deoxy-β-D-galactopyranosyl]oxy]-14,14-bis[[3-[[3-[[5-[[2-(acetylamino)-2-deoxy-β-D-galactopyranosyl]oxy]-1-oxopentyl]amino]propyl]amino]-3-oxopropoxy]methyl]-1,12,19,25-tetraoxo-16-oxa-13,20,24-triazanonacos-1-yl]-4-hydroxy-2-pyrrolidinyl]methyl hydrogen phosphate], complex with RNA (Um-sp-(2′-deoxy-2′-fluoro)A-sp-(2′-deoxy-2′-fluoro)A-(2′-deoxy-2′-fluoro)G-Am-(2′-deoxy-2′-fluoro)U-Gm-(2′-deoxy-2′-fluoro)A-Gm-(2′-deoxy-2′-fluoro)A-Cm-(2′-deoxy-2′-fluoro)A-Cm-(2′-deoxy-2′-fluoro)U-Cm-(2′-deoxy-2′-fluoro)U-Um-(2′-deoxy-2′-fluoro)U-Cm-(2′-deoxy-2′-fluoro)U-Gm-sp-Gm-sp-Um) (1:1) Givosiran, sold under the brand name Givlaari, is for the treatment of adults with acute …

Golodirsen, ゴロジルセン;

It’s only fair to share…   Golodirsen RNA, [P-deoxy-P-(dimethylamino)](2′,3′-dideoxy-2′,3′-imino-2′,3′-seco)(2’a→5′)(G-m5U-m5U-G-C-C-m5U-C-C-G-G-m5U-m5U-C-m5U-G-A-A-G-G-m5U-G-m5U-m5U-C), 5′-[P-[4-[[2-[2-(2-hydroxyethoxy)ethoxy]ethoxy]carbonyl]-1-piperazinyl]-N,N-dimethylphosphonamidate] Nucleic Acid Sequence Sequence Length: 25 Formula C305H481N138O112P25 CAS 1422959-91-8 Mol weight 8647.2841   Exon 53: NG-12-0163 Golodirsen SRP 4053 Nucleic Acid Sequence Sequence Length: 252 a 6 c 8 g 9 umodified FDA APPROVED, Vyondys 53, 019/12/12 Antisense oligonucleotide ゴロジルセン; Duchenne muscular dystrophy (DMD variant amenable …

FDA approves novel treatment Oxbryta (voxelotor) to target abnormality in sickle cell disease

It’s only fair to share… Today, the U.S. Food and Drug Administration granted accelerated approval to Oxbryta (voxelotor) for the treatment of sickle cell disease (SCD) in adults and pediatric patients 12 years of age and older. “Today’s approval provides additional hope to the 100,000 people in the U.S., and the more than 20 million …

FDA approves new treatment XCOPRI (cenobamate tablets) for adults with partial-onset seizures

It’s only fair to share… The U.S. Food and Drug Administration today approved XCOPRI (cenobamate tablets) to treat partial-onset seizures in adults. “XCOPRI is a new option to treat adults with partial-onset seizures, which is an often difficult-to-control condition that can have a significant impact on patient quality of life,” said Billy Dunn, M.D., director …