Category «FDA 2021»

Drospirenone

It’s only fair to share… Drospirenone FDA APPROVED 4/15/2021, To prevent pregnancy Nextstellis New Drug Application (NDA): 214154 Company: MAYNE PHARMA Label (PDF) Letter (PDF) Review Label (PDF) Drospirenone CAS Registry Number: 67392-87-4 CAS Name: (2¢S,6R,7R,8R,9S,10R,13S,14S,15S,16S)-1,3¢,4¢,6,7,8,9,10,11,12,13,14,15,16,20,21-Hexadecahydro-10,13-dimethylspiro[17H-dicyclopropa[6,7:15,16]cyclopenta[a]phenanthrene-17,2¢(5¢H)-furan]-3,5¢(2H)-dione Additional Names: 6b,7b,15b,16b-dimethylene-3-oxo-4-androstene-[17(b-1¢)-spiro-5¢]perhydrofuran-2¢-one; 6b,7b,15b,16b-dimethylen-3-oxo-17a-pregn-4-ene-21,17-carbolactone; dihydrospirorenone Manufacturers’ Codes: ZK-30595 Molecular Formula: C24H30O3 Molecular Weight: 366.49 Percent Composition: C 78.65%, H 8.25%, O 13.10% Literature References: Synthetic progestogen exhibiting antimineralocorticoid and antiandrogenic activity. Prepn: …

Samidorphan

It’s only fair to share… Samidorphan サミドルファン; Formula C21H26N2O4 CAS 852626-89-2 Mol weight 370.4421 FDA  APPROVED 5/28/2021 Lybalvi ALKS 33 ALKS-33 RDC-0313 RDC-0313-00 Product Ingredients UNII0AJQ5N56E0 CAS Number1204592-75-5 WeightAverage: 504.536 Monoisotopic: 504.210780618 Chemical FormulaC25H32N2O9 INGREDIENT UNII CAS INCHI KEY Samidorphan L-malate 0AJQ5N56E0 1204592-75-5 RARHXUAUPNYAJF-QSYGGRRVSA-N IUPAC Name (1R,9R,10S)-17-(cyclopropylmethyl)-3,10-dihydroxy-13-oxo-17-azatetracyclo[7.5.3.0^{1,10}.0^{2,7}]heptadeca-2,4,6-triene-4-carboxamide; (2S)-2-hydroxybutanedioic acid   MOA:mu-Opioid antagonist; delta-Opioid partial agonist; kappa-Opioid partial agonistsIndication:Alcohol …

Piflufolastat F 18 injection, Dcfpyl F-18

It’s only fair to share… Piflufolastat F 18 injection Dcfpyl F-18 CAS 207181-29-0 PLAIN F 1423758-00-2  WITHOUT RADIO LABEL C18 H23 F N4 O8, 441.4 L-Glutamic acid, N-[[[(1S)-1-carboxy-5-[[[6-(fluoro-18F)-3-pyridinyl]carbonyl]amino]pentyl]amino]carbonyl]- 2-(3-{1-carboxy-5-[(6-[18F]fluoro-pyridine-3-carbonyl)­ amino]-pentyl}ureido)-pentanedioic acid Other Names N-[[[(1S)-1-Carboxy-5-[[[6-(fluoro-18F)-3-pyridinyl]carbonyl]amino]pentyl]amino]carbonyl]-L-glutamic acid [18F]DCFPyl Dcfpyl F-18 (18F)Dcfpyl UNII-3934EF02T7 18F-DCFPyL 3934EF02T7 Progenics Pharmaceuticals, Inc. APPROVED 5/26/2021 fda, Pylarify For positron emission tomography imaging of prostate-specific membrane antigen-positive lesions in men with prostate …

Amivantamab

It’s only fair to share… (A chain) QVQLVESGGG VVQPGRSLRL SCAASGFTFS TYGMHWVRQA PGKGLEWVAV IWDDGSYKYY GDSVKGRFTI SRDNSKNTLY LQMNSLRAED TAVYYCARDG ITMVRGVMKD YFDYWGQGTL VTVSSASTKG PSVFPLAPSS KSTSGGTAAL GCLVKDYFPE PVTVSWNSGA LTSGVHTFPA VLQSSGLYSL SSVVTVPSSS LGTQTYICNV NHKPSNTKVD KRVEPKSCDK THTCPPCPAP ELLGGPSVFL FPPKPKDTLM ISRTPEVTCV VVDVSHEDPE VKFNWYVDGV EVHNAKTKPR EEQYNSTYRV VSVLTVLHQD WLNGKEYKCK VSNKALPAPI EKTISKAKGQ PREPQVYTLP PSREEMTKNQ VSLTCLVKGF YPSDIAVEWE SNGQPENNYK TTPPVLDSDG SFLLYSKLTV DKSRWQQGNV FSCSVMHEAL HNHYTQKSLS LSPGK (B chain) …

Pegcetacoplan

It’s only fair to share… Sequence: 1ICVWQDWGAH RCTXK Sequence: 1ICVWQDWGAH RCTXK Sequence Modifications Type Location Description terminal mod. Lys-15 C-terminal amide terminal mod. Lys-15′ C-terminal amide bridge Cys-2 – Cys-12 disulfide bridge, dimer bridge Lys-15 – Lys-15′ covalent bridge, dimer bridge Cys-2′ – Cys-12′ disulfide bridge, dimer uncommon Oaa-14 – uncommon Oaa-14′ – Pegcetacoplan ペグセタコプラン; …

Sotorasib

It’s only fair to share… Sotorasib 6-fluoro-7-(2-fluoro-6-hydroxyphenyl)-1-(4-methyl-2-propan-2-ylpyridin-3-yl)-4-[(2S)-2-methyl-4-prop-2-enoylpiperazin-1-yl]pyrido[2,3-d]pyrimidin-2-one AMG 510 AMG-510 AMG510 Formula C30H30F2N6O3 CAS 2296729-00-3 Mol weight 560.5944 FDA APPROVED, 2021/5/28 Lumakras Antineoplastic, Non-small cell lung cancer (KRAS G12C-mutated) ソトラシブ (JAN); 2296729-00-3 (racemate) 4-((S)-4-Acryloyl-2-methylpiperazin-1-yl)-6-fluoro-7-(2-fluoro-6-hydroxyphenyl)-1-(2-isopropyl-4-methylpyridin-3-yl)pyrido[2,3-d]pyrimidin-2(1H)-one 6-fluoro-7-(2-fluoro-6-hydroxyphenyl)-1-(4-methyl-2-propan-2-ylpyridin-3-yl)-4-[(2S)-2-methyl-4-prop-2-enoylpiperazin-1-yl]pyrido[2,3-d]pyrimidin-2-one Sotorasib [INN] 6-Fluoro-7-(2-fluoro-6-hydroxyphenyl)-1-(4-methyl-2-propan-2-ylpyridin-3-yl)-4-((2S)-2-methyl-4-prop-2-enoylpiperazin-1-yl)pyrido(2,3-d)pyrimidin-2-one Sotorasib (1M)-6-Fluoro-7-(2-fluoro-6-hydroxyphenyl)-1-[4-methyl-2-(propan-2-yl)pyridin-3-yl]-4-[(2S)-2-methyl-4-(prop-2-enoyl)piperazin-1-yl]pyrido[2,3-d]pyrimidin-2(1H)-one C30H30F2N6O3 : 560.59 [2296729-00-3] Sotorasib is an inhibitor of the RAS GTPase family. The molecular formula is C30H30F2N6O3, and the …

Infigratinib phosphate

It’s only fair to share… Infigratinib phosphate FDA APPR Truseltiq 2021/5/28 インフィグラチニブリン酸塩; 3-(2,6-dichloro-3,5-dimethoxyphenyl)-1-[6-[4-(4-ethylpiperazin-1-yl)anilino]pyrimidin-4-yl]-1-methylurea;phosphoric acid BGJ 398 BGJ-398 BGJ398 NVP-BGJ398 WHO 10032 Product Ingredients INGREDIENT UNII CAS INCHI KEY Infigratinib acetate 03D0789NYP 1310746-17-8 XHCQHOGMMJKLRU-UHFFFAOYSA-N Infigratinib hydrochloride WY8VD4RV77 1310746-15-6 VBAIJSJSFCXDJB-UHFFFAOYSA-N Infigratinib mesylate E223Z0KWCC 1310746-12-3 BXJJFNXYWJLBOS-UHFFFAOYSA-N Infigratinib phosphate 58BH47BV6S 1310746-10-1 GUQNHCGYHLSITB-UHFFFAOYSA-N International/Other BrandsTruseltiq (BridgeBio Pharma, Inc.)   Formula C26H31Cl2N7O3. H3PO4 …

Ibrexafungerp citrate

It’s only fair to share… Ibrexafungerp citrate アイブレキサフンジェルプクエン酸塩; Formula C44H67N5O4. C6H8O7 cas 1965291-08-0 free 1207753-03-4 Mol weight 922.1574 Brexafemme, fda approved 2021, 2021/6/1 Antifungal, Cell wall biosynthesis inhibitor, Treatment of invasive fungal infections due to Candida spp. or Aspergillus spp., vulvovaginal candidiasis SCY-078 citrate, MK-3118; SCY-078, WHO 10597 UNII-M4NU2SDX3E M4NU2SDX3E (1R,5S,6R,7R,10R,11R,14R,15S,20R,21R)-21-[(2R)-2-amino-2,3,3-trimethylbutoxy]-5,7,10,15-tetramethyl-7-[(2R)-3-methylbutan-2-yl]-20-(5-pyridin-4-yl-1,2,4-triazol-1-yl)-17-oxapentacyclo[13.3.3.01,14.02,11.05,10]henicos-2-ene-6-carboxylic acid;2-hydroxypropane-1,2,3-tricarboxylic acid Originator Merck & Co; SCYNEXIS Class Antifungals; Glycosides; …

Idecabtagene vicleucel

It’s only fair to share…   Idecabtagene vicleucel CAS 2306267-75-2 STN: BLA 125736 An autologous T lymphocyte-enriched cell transduced ex vivo with an anti-BCMA CAR lentiviral vector encoding a chimeric antigen receptor CAR, comprising a CD8 hinge and TM domain, 4-1BB costimulatory domain and CD3ζ signaling domain, targeting human B cell maturation antigen for cancer immunotherapy (Celgene …

Loncastuximab tesirine

It’s only fair to share…   Loncastuximab tesirine ZYNLONTA FDA APPROVED 2021/4/23 https://www.adcreview.com/wp-content/uploads/2019/06/15_ICML_Chiara-Tarantelli-ADCT_402_preclinical.pdf Formula C6544H10048N1718O2064S52 Exact mass 147387.9585 CAS 1879918-31-6 Efficacy Antineoplasitc, Anti-CD19 antibody   Disease Diffuse large B-cell lymphoma not otherwise specified [DS:H02434] Comment Antibody-drug conjugate Treatment of hematological cancers ロンカスツキシマブテシリン; ADCT-402, ADCX 19 Immunoglobulin G1, anti-(human CD19 antigen) (human-Mus musculus monoclonal RB4v1.2 γ1-chain), disulfide with human-Mus …