Category «APPROVALS 2020»

Vonicog alfa

It’s only fair to share… >>von Willebrand factor<<< MIPARFAGVLLALALILPGTLCAEGTRGRSSTARCSLFGSDFVNTFDGSMYSFAGYCSYL AGGCQKRSFSIIGDFQNGKRVSLSVYLGEFFDIHLFVNGTVTQGDQRVSMPYASKGLYLE TEAGYYKLSGEAYGFVARIDGSGNFQVLLSDRYFNKTCGLCGNFNIFAEDDFMTQEGTLT SDPYDFANSWALSSGEQWCERASPPSSSCNISSGEMQKGLWEQCQLLKSTSVFARCHPLV DPEPFVALCEKTLCECAGGLECACPALLEYARTCAQEGMVLYGWTDHSACSPVCPAGMEY RQCVSPCARTCQSLHINEMCQERCVDGCSCPEGQLLDEGLCVESTECPCVHSGKRYPPGT SLSRDCNTCICRNSQWICSNEECPGECLVTGQSHFKSFDNRYFTFSGICQYLLARDCQDH SFSIVIETVQCADDRDAVCTRSVTVRLPGLHNSLVKLKHGAGVAMDGQDIQLPLLKGDLR IQHTVTASVRLSYGEDLQMDWDGRGRLLVKLSPVYAGKTCGLCGNYNGNQGDDFLTPSGL AEPRVEDFGNAWKLHGDCQDLQKQHSDPCALNPRMTRFSEEACAVLTSPTFEACHRAVSP LPYLRNCRYDVCSCSDGRECLCGALASYAAACAGRGVRVAWREPGRCELNCPKGQVYLQC GTPCNLTCRSLSYPDEECNEACLEGCFCPPGLYMDERGDCVPKAQCPCYYDGEIFQPEDI FSDHHTMCYCEDGFMHCTMSGVPGSLLPDAVLSSPLSHRSKRSLSCRPPMVKLVCPADNL RAEGLECTKTCQNYDLECMSMGCVSGCLCPPGMVRHENRCVALERCPCFHQGKEYAPGET VKIGCNTCVCRDRKWNCTDHVCDATCSTIGMAHYLTFDGLKYLFPGECQYVLVQDYCGSN PGTFRILVGNKGCSHPSVKCKKRVTILVEGGEIELFDGEVNVKRPMKDETHFEVVESGRY IILLLGKALSVVWDRHLSISVVLKQTYQEKVCGLCGNFDGIQNNDLTSSNLQVEEDPVDF GNSWKVSSQCADTRKVPLDSSPATCHNNIMKQTMVDSSCRILTSDVFQDCNKLVDPEPYL DVCIYDTCSCESIGDCACFCDTIAAYAHVCAQHGKVVTWRTATLCPQSCEERNLRENGYE CEWRYNSCAPACQVTCQHPEPLACPVQCVEGCHAHCPPGKILDELLQTCVDPEDCPVCEV AGRRFASGKKVTLNPSDPEHCQICHCDVVNLTCEACQEPGGLVVPPTDAPVSPTTLYVED ISEPPLHDFYCSRLLDLVFLLDGSSRLSEAEFEVLKAFVVDMMERLRISQKWVRVAVVEY HDGSHAYIGLKDRKRPSELRRIASQVKYAGSQVASTSEVLKYTLFQIFSKIDRPEASRIA LLLMASQEPQRMSRNFVRYVQGLKKKKVIVIPVGIGPHANLKQIRLIEKQAPENKAFVLS SVDELEQQRDEIVSYLCDLAPEAPPPTLPPHMAQVTVGPGLLGVSTLGPKRNSMVLDVAF VLEGSDKIGEADFNRSKEFMEEVIQRMDVGQDSIHVTVLQYSYMVTVEYPFSEAQSKGDI LQRVREIRYQGGNRTNTGLALRYLSDHSFLVSQGDREQAPNLVYMVTGNPASDEIKRLPG DIQVVPIGVGPNANVQELERIGWPNAPILIQDFETLPREAPDLVLQRCCSGEGLQIPTLS PAPDCSQPLDVILLLDGSSSFPASYFDEMKSFAKAFISKANIGPRLTQVSVLQYGSITTI DVPWNVVPEKAHLLSLVDVMQREGGPSQIGDALGFAVRYLTSEMHGARPGASKAVVILVT DVSVDSVDAAADAARSNRVTVFPIGIGDRYDAAQLRILAGPAGDSNVVKLQRIEDLPTMV TLGNSFLHKLCSGFVRICMDEDGNEKRPGDVWTLPDQCHTVTCQPDGQTLLKSHRVNCDR GLRPSCPNSQSPVKVEETCGCRWTCPCVCTGSSTRHIVTFDGQNFKLTGSCSYVLFQNKE QDLEVILHNGACSPGARQGCMKSIEVKHSALSVELHSDMEVTVNGRLVSVPYVGGNMEVN VYGAIMHEVRFNHLGHIFTFTPQNNEFQLQLSPKTFASKTYGLCGICDENGANDFMLRDG TVTTDWKTLVQEWTVQRPGQTCQPILEEQCLVPDSSHCQVLLLPLFAECHKVLAPATFYA ICQQDSCHQEQVCEVIASYAHLCRTNGVCVDWRTPDFCAMSCPPSLVYNHCEHGCPRHCD GNVSSCGDHPSEGCFCPPDKVMLEGSCVPEEACTQCIGEDGVQHQFLEAWVPDHQPCQIC TCLSGRKVNCTTQPCPTAKAPTCGLCEVARLRQNADQCCPEYECVCDPVSCDLPPVPHCE RGLQPTLTNPGECRPNFTCACRKEECKRVSPPSCPPHRLPTLRKTQCCDEYECACNCVNS TVSCPLGYLASTATNDCGCTTTTCLPDKVCVHRSTIYPVGQFWEEGCDVCTCTDMEDAVM GLRVAQCSQKPCEDSCRSGFTYVLHEGECCGRCLPSACEVVTGSPRGDSQSSWKSVGSQW ASPENPCLINECVRVKEEVFIQQRNVSCPQLEVPVCPSGFQLSCKTSACCPSCRCERMEA CMLNGTVIGPGKTVMIDVCTTCRCMVQVGVISGFKLECRKTTCNPCPLGYKEENNTGECC GRCLPTACTIQLRGGQIMTLKRDETLQDGCDTHFCKVNERGEYFWEKRVTGCPPFDEHKC LAEGGKIMKIPGTCCDTCEEPECNDITARLQYVKVGSCKSEVEVDIHYCQGKCASKAMYS IDINDVQDQCSCCSPTRTEPMQVALHCTNGSVVYHEVLNAMECKCSPRKCSK …

Dofetilide

It’s only fair to share… Dofetilide 115256-11-6 [RN] 6756 b-((p-Methanesulfonamidophenethyl)methylamino)methanesulfono-p-phenetidide Methanesulfonamide, N-[4-[2-[methyl[2-[4-[(methylsulfonyl)amino]phenoxy]ethyl]amino]ethyl]phenyl]- MFCD00869707 [MDL number] Molecular FormulaC19H27N3O5S2 Average mass441.565 Da UK68798 UNII:R4Z9X1N2ND UNII-R4Z9X1N2ND Xelide β-((p-Methanesulfonamidophenethyl)methylamino)methanesulfono-p-phenetidide дофетилид دوفيتيليد 多非利特 N-[4-[2-[methyl[2-[4-[(methylsulfonyl)amino]phenoxy]ethyl]amino]ethyl]phenyl]-methanesulfonamide NCGC00164549-01 PB0478000 SMR000466333 Tikosyn (TN) Research Code:UK-68798 Trade Name:Tikosyn® MOA:Atrial potassium channel blocker Indication:Atrial flutter; Atrial fibrillation Status:ApprovedCompany:Pfizer (Originator)Sales: ATC Code:C01BD04 INDIA 31/7/2020 APPROVED CDSCO Dofetilide was first approved by …

Ansuvimab-zykl

It’s only fair to share… Ansuvimab-zykl FDA APPROVED, 12/21/2020, EBANGA To treat ebola https://www.fda.gov/drugs/drug-safety-and-availability/fda-approves-treatment-ebola-virus The U.S. Food and Drug Administration approved Ebanga (Ansuvimab-zykl), a human monoclonal antibody, for the treatment for Zaire ebolavirus (Ebolavirus) infection in adults and children. Ebanga blocks binding of the virus to the cell receptor, preventing its entry into the cell. Zaire ebolavirus is one …

Amikacin sulfate

It’s only fair to share… Amikacin sulfate アミカシン硫酸塩 , BB K 8 Formula C22H43N5O13. 2H2SO4 CAS 39831-55-5 FREE 37517-28-5  Mol weight 781.7595 EU APPROVED,  2020/10/27, Arikayce liposomal Antibacterial, Protein biosynthesis inhibitor (2S)-4-amino-N-[(1R,2S,3S,4R,5S)-5-amino-2-[(2S,3R,4S,5S,6R)-4-amino-3,5-dihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy-4-[(2R,3R,4S,5S,6R)-6-(aminomethyl)-3,4,5-trihydroxyoxan-2-yl]oxy-3-hydroxycyclohexyl]-2-hydroxybutanamide;sulfuric acid  Amikacin CAS Registry Number: 37517-28-5 CAS Name: O-3-Amino-3-deoxy-a-D-glucopyranosyl-(1®6)-O-[6-amino-6-deoxy-a-D-glucopyranosyl-(1®4)]-N1-[(2S)-4-amino-2-hydroxy-1-oxobutyl]-2-deoxy-D-streptamine Additional Names: 1-N-[L(-)-4-amino-2-hydroxybutyryl]kanamycin A Molecular Formula: C22H43N5O13 Molecular Weight: 585.60 Percent Composition: C 45.12%, H 7.40%, N 11.96%, O 35.52% Literature References: Semisynthetic aminoglycoside …

Lonafarnib

It’s only fair to share… Lonafarnib Molecular FormulaC27H31Br2ClN4O2 Average mass638.822 Da 193275-84-2 [RN] 1-Piperidinecarboxamide, 4-[2-[4-[(11R)-3,10-dibromo-8-chloro-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-yl]-1-piperidinyl]-2-oxoethyl]- 4-[2-[4-[(11R)-3,10-Dibromo-8-chloro-6,11-dihydro-5Hbenzo[5,6]cyclohepta[1,2-b]pyridin-11-yl]-1-piperidinyl]-2-oxoethyl]-1-piperidinecarboxamide 8191 (+)-4[2-[4-(8-Chloro-3,10-dibromo-6,11-dihydro-5H-benzo[5,6] cyclohepta[1,2-b]-pyridin-11(R)-yl-1-piperidinyl]-2-oxo-ethyl]-1-piperidinecarboxamide (R)-4-(2-(4-(3,10-dibromo-8-chloro-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-yl)piperidin-1-yl)-2-oxoethyl)piperidine-1-carboxamide 4-{2-[4-(3,10-dibromo-8-chloro-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-yl)piperidin-1-yl]-2-oxoethyl}piperidine-1-carboxamide D04768 lonafarnibum TM5989100 UNII:IOW153004F FDA APPROVED 11/20/2020, Zokinvy To treat rare conditions related to premature aging Press Release Drug Trials Snapshot лонафарниб [Russian] [INN] لونافارنيب [Arabic] [INN] 氯那法尼 [Chinese] [INN] Lonafarnib, sold under the brand name Zokinvy, is a medication used to reduce the risk …

Gallium 68 PSMA-11

It’s only fair to share…   Gallium 68 PSMA-11 FDA APPROVED, 12/1/2020, Gallium 68 PSMA-11 For detection and localization of prostate cancer Press Release Drug Trials Snapshot Chemical structure of 18F-labeled radiotracers. [18F]DCFPyL (A), [18F]PSMA-1007 (B), [18F]CTT1057 (C), (D) [18F]JK-PSMA-7 and (E) [18F]AIF-PSMA-11. The urea backbone of (A), (B), (D) and (E) is marked in blue, while the phosphoramidate …

Isatuximab

It’s only fair to share… (A chain) QVQLVQSGAE VAKPGTSVKL SCKASGYTFT DYWMQWVKQR PGQGLEWIGT IYPGDGDTGY AQKFQGKATL TADKSSKTVY MHLSSLASED SAVYYCARGD YYGSNSLDYW GQGTSVTVSS ASTKGPSVFP LAPSSKSTSG GTAALGCLVK DYFPEPVTVS WNSGALTSGV HTFPAVLQSS GLYSLSSVVT VPSSSLGTQT YICNVNHKPS NTKVDKKVEP KSCDKTHTCP PCPAPELLGG PSVFLFPPKP KDTLMISRTP EVTCVVVDVS HEDPEVKFNW YVDGVEVHNA KTKPREEQYN STYRVVSVLT VLHQDWLNGK EYKCKVSNKA LPAPIEKTIS KAKGQPREPQ VYTLPPSRDE LTKNQVSLTC LVKGFYPSDI AVEWESNGQP ENNYKTTPPV LDSDGSFFLY SKLTVDKSRW QQGNVFSCSV MHEALHNHYT QKSLSLSPGK (B chain) QVQLVQSGAE …

Viltolarsen

It’s only fair to share… Viltolarsen 维托拉生 ビルトラルセン Formula C244H381N113O88P20 CAS  2055732-84-6 Mol weight 6924.8155 APPROVED FDA 2020/8/12, Viltepso APPROVED JAPAN PMDA 2020/3/25, VILTEPSO   NCNP-01 NS-065 NS-065/NCNP-01 WHO 10771 WHO-10771 NAME DOSAGE STRENGTH ROUTE LABELLER MARKETING START MARKETING END Viltepso Injection, solution 250 mg/1 Intravenous Ns Pharma, Inc. 2020-08-13 Not applicable SYN Watanabe N, Nagata T, Satou …

Tucatinib

It’s only fair to share…   Tucatinib ツカチニブ; N6-(4,4-dimethyl-4,5-dihydro-1,3-oxazol-2-yl)-N4-(3-methyl-4-{[1,2,4]triazolo[1,5-a]pyridin-7-yloxy}phenyl)quinazoline-4,6-diamine Formula C26H24N8O2 CAS 937263-43-9 Mol weight 480.5212 To treat advanced unresectable or metastatic HER2-positive breast cancer Drug Trials Snapshot FDA APPROVED 4/17/2020 Tukysa ARRY 380 ARRY-380 ONT 380 ONT-380 Tucatinib (INN),[1] sold under the brand name Tukysa, is a small molecule inhibitor of HER2 for the treatment of HER2-positive breast cancer.[2][3] It was developed by Array …

Ripretinib

It’s only fair to share… Ripretinib リプレチニブ; Formula C24H21BrFN5O2 CAS 1442472-39-0 Mol weight 510.3582 Antineoplastic, Receptor tyrosine kinase inhibitor US FDA APPROVED 2020/5/15 QUINLOCK NAME DOSAGE STRENGTH ROUTE LABELLER MARKETING START MARKETING END Qinlock Tablet 50 mg Oral Deciphera Pharmaceuticals. Llc Not applicable Not applicable Qinlock Tablet 50 mg/1 Oral Deciphera Pharmaceuticals, LLC 2020-05-15 Not applicable …