Tag «fda 2019»

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 …

FDA approves first treatment Givlaari (givosiran) for inherited rare disease

It’s only fair to share… Today, the U.S. Food and Drug Administration granted approval to Givlaari (givosiran) for the treatment of adult patients with acute hepatic porphyria, a genetic disorder resulting in the buildup of toxic porphyrin molecules which are formed during the production of heme (which helps bind oxygen in the blood). “This buildup …

Afamelanotide, アファメラノチド , афамеланотид , أفاميلانوتيد , 阿法诺肽 ,

It’s only fair to share… Afamelanotide RN: 75921-69-6 Molecular Formula, C78-H111-N21-O19, Molecular Weight, 1646.8629 Synonyms 75921-69-6 AFAMELANOTIDE [MI] AFAMELANOTIDE AFAMELANOTIDE [INN] .ALPHA.-MELANOTROPIN (SWINE), 4-L-NORLEUCINE-7-D-PHENYLALANINE- AC-SER-TYR-SER-NLE-GLU-HIS-D-PHE-ARG-TRP-GLY-LYS-PRO-VAL-NH2 CUV1647 AFAMELANOTIDE [WHO-DD] AFAMELANOTIDE [USAN] ACETYL(4-(2S)-2-AMINOHEXANOIC ACID,7-D-PHENYLALANINE)HUMAN MELANOTROPIN ALPHA CUV-1647 MELANOTAN I MELANOTAN-1 alpha-Melanotropin, 4-L-norleucine-7-D-phenylalanine- Prevention of Phototoxicity in Adults with Erythropoietic Protoporphyria (EPP) UNII: QW68W3J66U アファメラノチド; афамеланотид [Russian] [INN] أفاميلانوتيد [Arabic] [INN] 阿法诺肽 [Chinese] [INN] Observations suggest …