Category «APPROVALS 2021»

RTS,S/AS01, RTS,S Mosquirix

It’s only fair to share… Sequence: 1MMAPDPNANP NANPNANPNA NPNANPNANP NANPNANPNA NPNANPNANP 51NANPNANPNA NPNANPNANP NANPNANPNA NPNKNNQGNG QGHNMPNDPN 101RNVDENANAN NAVKNNNNEE PSDKHIEQYL KKIKNSISTE WSPCSVTCGN 151GIQVRIKPGS ANKPKDELDY ENDIEKKICK MEKCSSVFNV VNSRPVTNME 201NITSGFLGPL LVLQAGFFLL TRILTIPQSL DSWWTSLNFL GGSPVCLGQN 251SQSPTSNHSP TSCPPICPGY RWMCLRRFII FLFILLLCLI FLLVLLDYQG 301MLPVCPLIPG STTTNTGPCK TCTTPAQGNS MFPSCCCTKP TDGNCTCIPI 351PSSWAFAKYL WEWASVRFSW LSLLVPFVQW FVGLSPTVWL SAIWMMWYWG 401PSLYSIVSPF IPLLPIFFCL WVYI RTS,S/AS01 (RTS,S) RTS,S/AS01, Mosquirix Cas 149121-47-1 203-400-Antigen CS …

Tisotumab vedotin

It’s only fair to share… Tisotumab vedotin チソツマブベドチン (遺伝子組換え) Immunoglobulin G1, anti-(human blood-coagulation factor III) (human monoclonal HuMax-TF heavy chain), disulfide with human monoclonal HuMax-TF κ-chain, dimer, tetrakis(thioether) with N-[[[4-[[N-[6-(3-mercapto-2,5-dioxo-1-pyrrolidinyl)-1-oxohexyl]-L-valyl-N5-(aminocarbonyl)-L-ornithyl]amino]phenyl]methoxy]carbonyl]-N-methyl-L-valyl-N-[(1S,2R)-4-[(2S)-2-[(1R,2R)-3-[[(1R,2S)-2-hydroxy-1-methyl-2-phenylethyl]amino]-1-methoxy-2-methyl-3-oxopropyl]-1-pyrrolidinyl]-2-methoxy-1-[(1S)-1-methylpropyl]-4-oxobutyl]-N-methyl-L-valinamide HuMax-TF-ADC Immunoglobulin G1, anti-(human tissue factor) (human monoclonal HuMax-TF heavy chain), disulfide with human monoclonal HuMax-TF κ-chain, dimer, tetrakis(thioether) with N-[[[4-[[N-[6-(3-mercapto-2,5-dioxo-1-pyrrolidinyl)-1-oxohexyl]-L-valyl-N5-(aminocarbonyl)-L-ornithyl]amino]phenyl]methoxy]carbonyl]-N-methyl-L-valyl-N-[(1S,2R)-4-[(2S)-2-[(1R,2R)-3-[[(1R,2S)-2-hydroxy-1-methyl-2-phenylethyl]amino]-1-methoxy-2-methyl-3-oxopropyl]-1-pyrrolidinyl]-2-methoxy-1-[(1S)-1-methylpropyl]-4-oxobutyl]-N-methyl-L-valinamide Protein Sequence Sequence Length: 1324, 448, …

Avacopan

It’s only fair to share… Avacopan アバコパン авакопан [Russian] [INN] أفاكوبان [Arabic] [INN] 阿伐可泮 [Chinese] [INN] Formula C33H35F4N3O2 CAS 1346623-17-3 Mol weight 581.6435 (2R,3S)-2-[4-(cyclopentylamino)phenyl]-1-(2-fluoro-6-methylbenzoyl)-N-[4-methyl-3-(trifluoromethyl)phenyl]piperidine-3-carboxamide (2R,3S)-2-(4-Cyclopentylaminophenyl)-l-(2-fluoro-6-methylbenzoyl)piperidine-3- carboxylic acid (4-methyl-3-trifluoromethylphenyl)amide 3-Piperidinecarboxamide, 2-[4-(cyclopentylamino)phenyl]-1-(2-fluoro-6-methylbenzoyl)-N-[4-methyl-3-(trifluoromethyl)phenyl]-, (2R,3S)- (2R,3S)-2-[4-(Cyclopentylamino)phenyl]-1-(2-fluoro-6-methylbenzoyl)-N-[4-methyl-3-(trifluoromethyl)phenyl]-3-piperidinecarboxamide (2R,3S)-2-[4-(cyclopentylamino)phenyl]-1-(2-fluoro-6-methylbenzoyl)-N-[4-methyl3-(trifluoromethyl)phenyl]piperidine-3-carboxamide APPROVED PMDA JAPAN 2021/9/27, Tavneos Anti-inflammatory, Complement C5a receptor antagonist Treatment of anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis Avacopan (2R,3S)-2-[4-(Cyclopentylamino)phenyl]-1-(2-fluoro-6-methylbenzoyl)-N-[4-methyl-3-(trifluoromethyl)phenyl]piperidine-3-carboxamide C33H35F4N3O2 : 581.64 [1346623-17-3] CCX 168 Avacopan wasunder investigation in clinical trial …

BIAPENEM

It’s only fair to share… Biapenem Molecular FormulaC15H18N4O4S Average mass350.393 Da Biapenern CL 186-815 LJ C10,627 LJ C10627 LJC 10627 MFCD00864863 [MDL number] omegacin YR5U3L9ZH1 (4R,5S,6S)-3-((6,7-dihydro-5H-pyrazolo[1,2-a][1,2,4]triazol-4-ium-6-yl)thio)-6-((R)-1-hydroxyethyl)-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylate [4R-[4a,5b,6b(R*)]]-6-[[2-Carboxy-6-(1-hydroxyethyl)-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-en-3-yl]thio]-6,7-dihydro-5 H-pyrazolo[1,2-a][1,2,4]triazol-4-ium inner salt 120410-24-4 [RN] 5H-Pyrazolo[1,2-a][1,2,4]triazol-4-ium, 6-[[(4R,5S,6S)-2-carboxy-6-[(1R)-1-hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-en-3-yl]thio]-6,7-dihydro-, inner salt [ACD/Index Name] 6-[[(4R,5S,6S)-2-Carboxy-6-[(1R)-1-hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-en-3-yl]thio]-6,7-dihydro-5H-pyrazolo[1,2-a][1,2,4]triazol-4-ium inner salt 7074 (4R,5S,6S)-3-(6,7-Dihydro-5H-pyrazolo[1,2-a][1,2,4]triazol-4-ium-6-ylsulfanyl)-6-[(1R)-1-hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylate TL8000539 UNII:YR5U3L9ZH1 UNII-YR5U3L9ZH1 биапенем بيابينام 比阿培南 P12-KU4322-43245-1 INDIA CDSCO APPROVED 25 SEPT 2021, BDR PHARMA,   …

Mobocertinib

It’s only fair to share… Mobocertinib 1847461-43-1 MF C32H39N7O4 MW 585.70 propan-2-yl 2-[4-[2-(dimethylamino)ethyl-methylamino]-2-methoxy-5-(prop-2-enoylamino)anilino]-4-(1-methylindol-3-yl)pyrimidine-5-carboxylate TAK-788, AP32788, TAK788, UNII-39HBQ4A67L, AP-32788, 39HBQ4A67L US10227342, Example 10, MFCD32669806, NSC825519, s6813, TAK-788;AP32788, WHO 11183 NSC-825519, example 94 [WO2015195228A1], GTPL10468, BDBM368374, BCP31045, EX-A3392 US FDA APPROVED 9/15/2021, Exkivity, To treat locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutation   Mobocertinib succinate Chemical Structure CAS No. : 2389149-74-8 Molecular Weight 703.78 Formula C₃₆H₄₅N₇O₈ Mobocertinib …

Vosoritide

It’s only fair to share… PGQEHPNARK YKGANKKGLS KGCFGLKLDR IGSMSGLGC (Disulfide bridge: 23-39)   H-Pro-Gly-Gln-Glu-His-Pro-Asn-Ala-Arg-Lys-Tyr-Lys-Gly-Ala-Asn-Lys-Lys-Gly-Leu-Ser-Lys-Gly-Cys(1)-Phe-Gly-Leu-Lys-Leu-Asp-Arg-Ile-Gly-Ser-Met-Ser-Gly-Leu-Gly-Cys(1)-OH PGQEHPNARKYKGANKKGLSKGCFGLKLDRIGSMSGLGC H-PGQEHPNARKYKGANKKGLSKGC(1)FGLKLDRIGSMSGLGC(1)-OH PEPTIDE1{P.G.Q.E.H.P.N.A.R.K.Y.K.G.A.N.K.K.G.L.S.K.G.C.F.G.L.K.L.D.R.I.G.S.M.S.G.L.G.C}$PEPTIDE1,PEPTIDE1,23:R3-39:R3$$$ L-prolyl-glycyl-L-glutaminyl-L-alpha-glutamyl-L-histidyl-L-prolyl-L-asparagyl-L-alanyl-L-arginyl-L-lysyl-L-tyrosyl-L-lysyl-glycyl-L-alanyl-L-asparagyl-L-lysyl-L-lysyl-glycyl-L-leucyl-L-seryl-L-lysyl-glycyl-L-cysteinyl-L-phenylalanyl-glycyl-L-leucyl-L-lysyl-L-leucyl-L-alpha-aspartyl-L-arginyl-L-isoleucyl-glycyl-L-seryl-L-methionyl-L-seryl-glycyl-L-leucyl-glycyl-L-cysteine (23->39)-disulfide (4R,10S,16S,19S,22S,28S,31S,34S,37S,40S,43S,49S,52R)-52-[[2-[[(2S)-6-amino-2-[[(2S)-2-[[(2S)-2-[[2-[[(2S)-6-amino-2-[[(2S)-6-amino-2-[[(2S)-4-amino-2-[[(2S)-2-[[2-[[(2S)-6-amino-2-[[(2S)-2-[[(2S)-6-amino-2-[[(2S)-2-[[(2S)-2-[[(2S)-4-amino-2-[[(2S)-1-[(2S)-2-[[(2S)-2-[[(2S)-5-amino-5-oxo-2-[[2-[[(2S)-pyrrolidine-2-carbonyl]amino]acetyl]amino]pentanoyl]amino]-4-carboxybutanoyl]amino]-3-(1H-imidazol-5-yl)propanoyl]pyrrolidine-2-carbonyl]amino]-4-oxobutanoyl]amino]propanoyl]amino]-5-carbamimidamidopentanoyl]amino]hexanoyl]amino]-3-(4-hydroxyphenyl)propanoyl]amino]hexanoyl]amino]acetyl]amino]propanoyl]amino]-4-oxobutanoyl]amino]hexanoyl]amino]hexanoyl]amino]acetyl]amino]-4-methylpentanoyl]amino]-3-hydroxypropanoyl]amino]hexanoyl]amino]acetyl]amino]-40-(4-aminobutyl)-49-benzyl-28-[(2S)-butan-2-yl]-31-(3-carbamimidamidopropyl)-34-(carboxymethyl)-16,22-bis(hydroxymethyl)-10,37,43-tris(2-methylpropyl)-19-(2-methylsulfanylethyl)-6,9,12,15,18,21,24,27,30,33,36,39,42,45,48,51-hexadecaoxo-1,2-dithia-5,8,11,14,17,20,23,26,29,32,35,38,41,44,47,50-hexadecazacyclotripentacontane-4-carboxylic acid Vosoritide Formula C176H290N56O51S3 CAS 1480724-61-5 Mol weight 4102.7254 1480724-61-5 [RN] BMN 111 L-Cysteine, L-prolylglycyl-L-glutaminyl-L-α-glutamyl-L-histidyl-L-prolyl-L-asparaginyl-L-alanyl-L-arginyl-L-lysyl-L-tyrosyl-L-lysylglycyl-L-alanyl-L-asparaginyl-L-lysyl-L-lysylglycyl-L-leucyl-L-seryl-L-lysylglycyl-L-cysteinyl-L-phenylalanylglycyl-L-leucyl-L-lysyl-L-leucyl-L-α-aspartyl-L-arginyl-L-isoleucylglycyl-L-seryl-L-methionyl-L-serylglycyl-L-leucylglycyl-, cyclic (23→39)-disulfide L-prolylglycyl-(human C-type natriuretic peptide-(17-53)-peptide (CNP-37)), cyclic-(23-39)-disulfide UNII:7SE5582Q2P восоритид [Russian] [INN] فوسوريتيد [Arabic] [INN] 伏索利肽 [Chinese] [INN] Voxzogo, 2021/8/26 EU APPROVED Product details Name Voxzogo Agency product number …

Ferric pyrophosphate citrate

It’s only fair to share…   Ferric pyrophosphate citrate 1802359-96-1 tetrairon(3+) bis((phosphonooxy)phosphonic acid) tris(2-hydroxypropane-1,2,3-tricarboxylate) (hydrogen phosphonooxy)phosphonate Iron(3+) diphosphate (4:3) Proper name: ferric pyrophosphate citrate Chemical names: Iron (3+) cation; 2-oxidopropane-1,2,3-tricarboxylate; diphosphate 1,2,3-propanetricarboxylic acid, 2-hydroxy-, iron (3+), diphosphate Molecular formula: [Fe4 3+(C6H5O7)3(P2O7)3] Molecular mass: 1313 Physicochemical properties: TRIFERIC AVNU (ferric pyrophosphate citrate) contains no asymmetric centers. …

Pegvaliase

It’s only fair to share…     Pegvaliase (2S)-2-amino-6-[6-(2-methoxyethoxy)hexanoylamino]hexanoic acid CAS 1585984-95-7 Molecular FormulaC15H30N2O5 Average mass318.409 Da BMN-165 Palynziq pegvaliase pegvaliase-pqpz L-Lysine, N6-[6-(2-methoxyethoxy)-1-oxohexyl]- N6-[6-(2-Methoxyethoxy)hexanoyl]-L-lysine AUSTRALIA APPROVAL 2021 PALYNZIQ Evaluation commenced: 30 Sep 2020 Registration decision: 6 Jul 2021 Date registered: 14 Jul 2021 Approval time: 166 (175 working days) pegvaliase BioMarin Pharmaceutical Australia Pty Ltd PALYNZIQ …

Saquinavir

It’s only fair to share… Saquinavir, Ro 31 8959, Ro 31-8959, RO 31-8959/000, Ro 318959, RO-31-8959/000, Sch 52852, SCH-52852 (2S)-N-[(2S,3R)-4-[(3S,4aS,8aS)-3-(tert-butylcarbamoyl)-decahydroisoquinolin-2-yl]-3-hydroxy-1-phenylbutan-2-yl]-2-[(quinolin-2-yl)formamido]butanediamide (2S)-N-[(2S,3R)-4-[(3S,4aS,8aS)-3-(tert-butylcarbamoyl)-3,4,4a,5,6,7,8,8a-octahydro-1H-isoquinolin-2-yl]-3-hydroxy-1-phenylbutan-2-yl]-2-(quinoline-2-carbonylamino)butanediamide (-)-cis-N-tert-butyldecahydro-2-{(2R,3S)-2-hydroxy-4-phenyl-3-{[N-(2-quinolylcarbonyl)-L-asparaginyl]amino}butyl}-(3S,4aS,8aS)-isoquinoline-3 carboxamide monomethanesulfonate Product Ingredients INGREDIENT UNII CAS INCHI KEY Saquinavir mesylate UHB9Z3841A 149845-06-7 IRHXGOXEBNJUSN-YOXDLBRISA-N   CAS Registry Number: 127779-20-8 CAS Name: (2S)-N1[(1S,2R)-3-[(3S,4aS,8aS)-3-[[(1,1-Dimethylethyl)amino]carbonyl]octahydro-2(1H)-isoquinolinyl]-2-hydroxy-1-(phenylmethyl)propyl]-2-[(2-quinolinylcarbonyl)amino]butanediamide Additional Names: (S)-N-[(aS)-a-[(1R)-2-[(3S,4aS,8aS)-3-(tert-butylcarbamoyl)octahydro-2(1H)-isoquinolyl]-1-hydroxyethyl]phenethyl]-2-quinaldamido succinamide; N-tert-butyldecahydro-2-[2(R)-hydroxy-4-phenyl-3(S)-[[N-(2-quinolylcarbonyl)-L-asparaginyl]amino]butyl](4aS,8aS)-isoquinoline-3(S)-carboxamide Manufacturers’ Codes: Ro-31-8959 Molecular Formula: C38H50N6O5 Molecular Weight: 670.84 Percent Composition: C 68.04%, H …

Benzonatate

It’s only fair to share… Benzonatate Molecular FormulaC30H53NO11 Average mass603.742 Da 104-31-4 [RN] 2,5,8,11,14,17,20,23,26-Nonaoxaoctacosan-28-yl 4-(butylamino)benzoate бензонатат بنزوناتات 苯佐那酯 ベンゾナテート; KM 65 2,5,8,11,14,17,20,23,26-nonaoxaoctacosan-28-yl 4-(butylamino)benzoate 2-[2-[2-[2-[2-[2-[2-[2-(2-methoxyethoxy)ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethyl 4-(butylamino)benzoate Benzonatate bulk and Benzonatate capsules 100mg, cdsco india 2021, 15.07.2021 For the treatment of refractory cough   CAS Registry Number: 104-31-4 CAS Name: 4-(Butylamino)benzoic acid 3,6,9,12,15,18,21,24,27-nonaoxaoctacos-1-yl ester Additional Names: nonaethyleneglycol monomethyl ether p-n-butylaminobenzoate; p-butylaminobenzoic acid w-O-methylnonaethyleneglycol ester; benzononatine …