Category «FDA 2021»

Dostarlimab

It’s only fair to share… (Heavy chain) EVQLLESGGG LVQPGGSLRL SCAASGFTFS SYDMSWVRQA PGKGLEWVST ISGGGSYTYY QDSVKGRFTI SRDNSKNTLY LQMNSLRAED TAVYYCASPY YAMDYWGQGT TVTVSSASTK GPSVFPLAPC SRSTSESTAA LGCLVKDYFP EPVTVSWNSG ALTSGVHTFP AVLQSSGLYS LSSVVTVPSS SLGTKTYTCN VDHKPSNTKV DKRVESKYGP PCPPCPAPEF LGGPSVFLFP PKPKDTLMIS RTPEVTCVVV DVSQEDPEVQ FNWYVDGVEV HNAKTKPREE QFNSTYRVVS VLTVLHQDWL NGKEYKCKVS NKGLPSSIEK TISKAKGQPR EPQVYTLPPS QEEMTKNQVS LTCLVKGFYP SDIAVEWESN GQPENNYKTT PPVLDSDGSF FLYSRLTVDK SRWQEGNVFS CSVMHEALHN HYTQKSLSLS LGK (Light chain) DIQLTQSPSF …

DEXMETHYLPHENIDATE

It’s only fair to share… DEXMETHYLPHENIDATE SynonymsDexmethylphenidate HCl, UNII1678OK0E08, CAS Number19262-68-1, WeightAverage: 269.77 Chemical FormulaC14H20ClNO2 methyl (2R)-2-phenyl-2-[(2R)-piperidin-2-yl]acetate hydrochloride CAS Number 40431-64-9  as HCl: 19262-68-1 PubChem CID 154101 as HCl: 154100 IUPHAR/BPS 7554 DrugBank DB06701  as HCl: DBSALT001458 ChemSpider 135807  as HCl: 135806 UNII M32RH9MFGP as HCl: 1678OK0E08 Trade Name:Focalin® / Attenade®MOA:Norepinephrine-dopamine reuptake inhibitorIndication:Attention deficit hyperactivity disorder (ADHD)Status:ApprovedCompany:Novartis (Originator) , CelgeneSales:$365 Million (Y2015);  $492 Million …

Serdexmethylphenidate

It’s only fair to share… Serdexmethylphenidate Molecular FormulaC25H30ClN3O8 Average mass535.974 Da CAS 1996626-30-2      L-Serine, N-[[1-[[[[(2R)-2-[(1R)-2-methoxy-2-oxo-1-phenylethyl]-1-piperidinyl]carbonyl]oxy]methyl]-3-pyridiniumyl]carbonyl]-, chloride (1:1) N-[(1-{[({(2R)-2-[(1R)-2-Methoxy-2-oxo-1-phenylethyl]-1-piperidinyl}carbonyl)oxy]methyl}-3-pyridiniumyl)carbonyl]-L-serine chloride Azstarys, FDA APPROVED, 3/2/2021, Products on NDA 212994, Type 1 – New Molecular Entity and Type 4 – New Combination Serdexmethylphenidate Chloride (SDX), SDX or KP145 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212994s000lbl.pdf   Molecular Formula C25H30ClN3O8 Synonyms UNII-FN54BT298Y KP415 Cl Serdexmethylphenidate chloride FN54BT298Y …

Sacituzumab govitecan-hziy

It’s only fair to share…   Sacituzumab govitecan-hziy 1601.8 g/mol C76H104N12O24S (2R)-2-amino-3-[1-[[4-[[1-[2-[2-[2-[2-[2-[2-[2-[2-[2-[[2-[2-[[(2S)-6-amino-1-[4-[[(19S)-10,19-diethyl-7-hydroxy-14,18-dioxo-17-oxa-3,13-diazapentacyclo[11.8.0.02,11.04,9.015,20]henicosa-1(21),2,4(9),5,7,10,15(20)-heptaen-19-yl]oxycarbonyloxymethyl]anilino]-1-oxohexan-2-yl]amino]-2-oxoethoxy]acetyl]amino]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethyl]triazol-4-yl]methylcarbamoyl]cyclohexyl]methyl]-2,5-dioxopyrrolidin-3-yl]sulfanylpropanoic acid Trodelvy  hRS 7SN38 hRS7-SN38 IMMU 132 IMMU-132 CAS: 1491917-83-9 M9BYU8XDQ6 EX-A4354 UNII-DA64T2C2IO component ULRUOUDIQPERIJ-PQURJYPBSA-N UNII-SZB83O1W42 component ULRUOUDIQPERIJ-PQURJYPBSA-N Efficacy Antineoplastic, Topoisomerase I inhibitor   Disease Breast cancer (triple negative) Sacituzumab Govitecan is an antibody drug conjugate containing the humanized monoclonal antibody, hRS7, against tumor-associated calcium signal transducer …

Dasiglucagon

It’s only fair to share…       Dasiglucagon Treatment of Hypoglycemia in Type 1 and Type 2 Diabetes Patients Formula C152H222N38O50 CAS 1544300-84-6 Mol weight 3381.6137 FDA APPROVED,  2021/3/22, Zegalogue Zealand Pharma A/S UNIIAD4J2O47FQ HypoPal rescue pen SVG Image IUPAC Condensed H-His-Ser-Gln-Gly-Thr-Phe-Thr-Ser-Asp-Tyr-Ser-Lys-Tyr-Leu-Asp-Aib-Ala-Arg-Ala-Glu-Glu-Phe-Val-Lys-Trp-Leu-Glu-Ser-Thr-OH Sequence HSQGTFTSDYSKYLDXARAEEFVKWLEST HELM PEPTIDE1{H.S.Q.G.T.F.T.S.D.Y.S.K.Y.L.D.[Aib].A.R.A.E.E.F.V.K.W.L.E.S.T}$$$$ IUPAC L-histidyl-L-seryl-L-glutaminyl-glycyl-L-threonyl-L-phenylalanyl-L-threonyl-L-seryl-L-alpha-aspartyl-L-tyrosyl-L-seryl-L-lysyl-L-tyrosyl-L-leucyl-L-alpha-aspartyl-alpha-methyl-alanyl-L-alanyl-L-arginyl-L-alanyl-L-alpha-glutamyl-L-alpha-glutamyl-L-phenylalanyl-L-valyl-L-lysyl-L-tryptophyl-L-leucyl-L-alpha-glutamyl-L-seryl-L-threonine (4S)-4-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-6-amino-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S,3R)-2-[[(2S)-2-[[(2S,3R)-2-[[2-[[(2S)-5-amino-2-[[(2S)-2-[[(2S)-2-amino-3-(1H-imidazol-4-yl)propanoyl]amino]-3-hydroxypropanoyl]amino]-5-oxopentanoyl]amino]acetyl]amino]-3-hydroxybutanoyl]amino]-3-phenylpropanoyl]amino]-3-hydroxybutanoyl]amino]-3-hydroxypropanoyl]amino]-3-carboxypropanoyl]amino]-3-(4-hydroxyphenyl)propanoyl]amino]-3-hydroxypropanoyl]amino]hexanoyl]amino]-3-(4-hydroxyphenyl)propanoyl]amino]-4-methylpentanoyl]amino]-3-carboxypropanoyl]amino]-2-methylpropanoyl]amino]propanoyl]amino]-5-carbamimidamidopentanoyl]amino]propanoyl]amino]-5-[[(2S)-1-[[(2S)-1-[[(2S)-1-[[(2S)-6-amino-1-[[(2S)-1-[[(2S)-1-[[(2S)-4-carboxy-1-[[(2S)-1-[[(1S,2R)-1-carboxy-2-hydroxypropyl]amino]-3-hydroxy-1-oxopropan-2-yl]amino]-1-oxobutan-2-yl]amino]-4-methyl-1-oxopentan-2-yl]amino]-3-(1H-indol-3-yl)-1-oxopropan-2-yl]amino]-1-oxohexan-2-yl]amino]-3-methyl-1-oxobutan-2-yl]amino]-1-oxo-3-phenylpropan-2-yl]amino]-4-carboxy-1-oxobutan-2-yl]amino]-5-oxopentanoic acid . [16-(2-methylalanine)(S>X),17-L-alanine(R>A),20-L-α-glutamyl(Q>E),21-L-αglutamyl(D>E),24-L-lysyl(Q>K),27-L-α-glutamyl(M>E),28-L-serine(N>S)]human glucagon L-Threonine, L-histidyl-L-seryl-L-glutaminylglycyl-L-threonyl-L- …

Lisocabtagene maraleucel

It’s only fair to share… Lisocabtagene maraleucel (liso-cel; JCAR017; Anti-CD19 CAR T-Cells) is an investigational chimeric antigen receptor (CAR) T-cell therapy designed to target CD19, [1][2] which is a surface glycoprotein expressed during normal B-cell development and maintained following malignant transformation of B cells. [3][4][5] Liso-cel CAR T-cells aim to target and CD-19 expressing cells through a CAR construct …

Casimersen

It’s only fair to share…   Casimersen カシメルセン; RNA, [P-deoxy-P-(dimethylamino)](2′,3′-dideoxy-2′,3′-imino-2′,3′-seco)(2’a→5′)(C-A-A-m5U-G-C-C-A-m5U-C-C-m5U-G-G-A-G-m5U-m5U-C-C-m5U-G), 5′-[P-[4-[[2-[2-(2-hydroxyethoxy)ethoxy]ethoxy]carbonyl]-1-piperazinyl]-N,N-dimethylphosphonamidate] Formula C268H424N124O95P22 CAS 1422958-19-7 Mol weight 7584.4307 FDA 2021/2/25 , Amondys 45, Antisense oligonucleotide Treatment of Duchenne muscular dystrophy Nucleic Acid Sequence Sequence Length: 224 a 7 c 5 g 6 umodified Exon-45: NG-12-0064 SRP-4045 WHO 10354 Casimersen, sold under the brand name Amondys 45, is an antisense oligonucleotide medication used …

Fosdenopterin hydrobromide

It’s only fair to share… Fosdenopterin hydrobromide FDA APPR 2021/2/26, NULIBRY BBP-870/ORGN001 a cyclic pyranopterin monophosphate (cPMP) substrate replacement therapy, for the treatment of patients with molybdenum cofactor deficiency (MoCD) Type A. ホスデノプテリン臭化水素酸塩水和物; Formula C10H14N5O8P. 2H2O. HBr CAS 2301083-34-9DIHYDRATE Mol weight 480.1631 2301083-34-9 (1R,10R,12S,17R)-5-amino-11,11,14-trihydroxy-14-oxo-13,15,18-trioxa-2,4,6,9-tetraza-14λ5-phosphatetracyclo[8.8.0.03,8.012,17]octadeca-3(8),4-dien-7-one;dihydrate;hydrobromide 1,3,2-DIOXAPHOSPHORINO(4′,5′:5,6)PYRANO(3,2-G)PTERIDIN-10(4H)-ONE, 8-AMINO-4A,5A,6,9,11,11A,12,12A-OCTAHYDRO-2,12,12-TRIHYDROXY-, 2-OXIDE, HYDROBROMIDE, HYDRATE (1:1:2), (4AR,5AR,11AR,12AS)- CYCLIC PYRANOPTERIN MONOPHOSPHATE MONOHYDROBROMIDE DIHYDRATE …

Evinacumab

It’s only fair to share… (Heavy chain) EVQLVESGGG VIQPGGSLRL SCAASGFTFD DYAMNWVRQG PGKGLEWVSA ISGDGGSTYY ADSVKGRFTI SRDNSKNSLY LQMNSLRAED TAFFYCAKDL RNTIFGVVIP DAFDIWGQGT MVTVSSASTK GPSVFPLAPC SRSTSESTAA LGCLVKDYFP EPVTVSWNSG ALTSGVHTFP AVLQSSGLYS LSSVVTVPSS SLGTKTYTCN VDHKPSNTKV DKRVESKYGP PCPPCPAPEF LGGPSVFLFP PKPKDTLMIS RTPEVTCVVV DVSQEDPEVQ FNWYVDGVEV HNAKTKPREE QFNSTYRVVS VLTVLHQDWL NGKEYKCKVS NKGLPSSIEK TISKAKGQPR EPQVYTLPPS QEEMTKNQVS LTCLVKGFYP SDIAVEWESN GQPENNYKTT PPVLDSDGSF FLYSRLTVDK SRWQEGNVFS CSVMHEALHN HYTQKSLSLS LGK (Light chain) …

Umbralisib

It’s only fair to share… Umbralisib tosylate Formula C31H24F3N5O3. C7H8O3S Cas 1532533-72-4 FREE 1532533-67-7 Mol weight 743.7508 FDA APPR 2021/2/5 ウムブラリシブトシル酸塩; Treatment of cancer and B-cell related disorders Antineoplastic RP-5152; RP-5237; PI3K delta inhibitors (cancer), Rhizen/Incozen; PI3K delta inhibitors (B-cell lymphoma/hematological cancers), Incozen/Rhizen; TGR-1202; TG-1202; RV-1001; umbralisib tosylate; umbralisib; RP-5264; RP-5307; dual PI3Kdelta/CK1 inhibitor (cancer), TG Therapeutics; …