Tag «APPROVALS 2020»

Azelnidipine

It’s only fair to share… Azelnidipine C33H34N4O6, 582.6 g/mol CAS 123524-52-7 3-(1-Benzhydrylazetidin-3-yl) 5-isopropyl 2-amino-6-methyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate CS-905, RS-9054 3,5-PYRIDINEDICARBOXYLIC ACID, 2-AMINO-1,4-DIHYDRO-6-METHYL-4-(3-NITROPHENYL)-, 3-[1-(DIPHENYLMETHYL)-3-AZETIDINYL] 5-(1-METHYLETHYL) ESTER Approved India cdsco 2020 SYN REF https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4245158/ MP 95-98 °C AND NMR WO 2004058745 . EP 266922  Azelnidipine is a dihydropyridine calcium channel blocker. It is marketed by Daiichi-Sankyo pharmaceuticals, Inc. in Japan. It has a gradual onset of action …

Fenfluramine Hydrochloride

It’s only fair to share… Fenfluramine DEA No. 1670 S 768 2020/12/18, FDA APPROVED, Fintepla Fenfluramine hydrochloride Formula C12H16F3N. HCl CAS 404-82-0 458-24-2 (FREE) Mol weight 267.7183 Antiobesity Efficacy Appetite suppressant   Disease Dravet syndrome (+-)-Fenfluramine chloride (+-)-Fenfluramine hydrochloride Racemic fenfluramine hydrochloride Fenfluramine hydrochloride [USAN] AHR 3002 EINECS 206-968-2 1-(m-Trifluoromethylphenyl)-2-(ethylamino)propane hydrochloride AHR-3002 Research Code:ZX-008 MOA:Serotonin agonist …

Tazemetostat

It’s only fair to share…     Tazemetostat Current developer:  Epizyme, Inc., Cambridge, MA 02139. EPZ-6438 (Tazemetostat) CAS: 1403254-99-8 HBR 1467052-75-0 タゼメトスタット臭化水素酸塩 Current developer:  Epizyme, Inc., Cambridge, MA 02139. EPZ-6438 (Tazemetostat) CAS: 1403254-99-8 HBR Chemical Formula: C34H44N4O4 Exact Mass: 572.33626   USFDA APPROVED 23/1/2020 AS HBR SALT, TAZVERIK, EPIZYME N-((4,6-dimethyl-2-oxo-1,2-dihydropyridin-3-yl)methyl)-5-(ethyl(tetrahydro-2H-pyran-4-yl)amino)-4-methyl-4′-(morpholinomethyl)-[1,1′-biphenyl]-3-carboxamide SIMLES: O=C(C1=CC(C2=CC=C(CN3CCOCC3)C=C2)=CC(N(CC)C4CCOCC4)=C1C)NCC5=C(C)C=C(C)NC5=O (1,1′-Biphenyl)-3-carboxamide, N-((1,2-dihydro-4,6-dimethyl-2-oxo-3-pyridinyl)methyl)-5-(ethyl(tetrahydro-2H-pyran-4-yl)amino)-4-methyl-4′-(4-morpholinylmethyl)- N-((4,6-Dimethyl-2-oxo-1,2-dihydropyridin-3-yl)methyl)-5-(ethyl(oxan-4-yl)amino)-4-methyl-4′-((morpholin-4-yl)methyl)(1,1′-biphenyl)-3-carboxamide …

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 …

Berotralstat

It’s only fair to share… Berotralstat CAS  1809010-50-1 DIHCl 1809010-52-3 Molecular Formula, C30-H26-F4-N6-O, Molecular Weight, 562.5684 1-(3-(Aminomethyl)phenyl)-N-(5-((R)-(3-cyanophenyl)((cyclopropylmethyl)amino)methyl)-2-fluorophenyl)-3-(trifluoromethyl)-1H-pyrazole-5-carboxamide 1H-Pyrazole-5-carboxamide, 1-(3-(aminomethyl)phenyl)-N-(5-((R)-(3-cyanophenyl)((cyclopropylmethyl)amino)methyl)-2-fluorophenyl)-3-(trifluoromethyl)- To treat patients with hereditary angioedema FDA APPROVED 12/4/2020, Orladeyo, 110MG CAPSULE 0RAL New Drug Application (NDA): 214094 Company: BIOCRYST PHARMACEUTICALS INC New Drug Application (NDA): 214094 Company: BIOCRYST PHARMACEUTICALS INC Berotralstat Hydrochloride 1-[3-(Aminomethyl)phenyl]-N-(5-{(1R)-(3-cyanophenyl)[(cyclopropylmethyl)amino]methyl}-2-fluorophenyl)-3-(trifluoromethyl)-1H-pyrazole-5-carboxamide dihydrochloride C30H26F4N6O▪2HCl : 635.48 [1809010-52-3] Berotralstat, also known as BCX-7353, is a kallikrein inhibitor. BCX7353 …

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 …

Cetuximab sarotalocan sodium

It’s only fair to share… Cetuximab Sarotalocan Sodium (Genetical Recombination) Cetuximab Sarotalocan Sodium is an antibody-drug-conjugate (molecular weight: 156,000-158,000) consisting of tetrasodium salt of Sarotalocan (6-({[3-({(OC-6-13)-bis({3-[bis(3-sulfopropyl)(3-sulfonatopropyl)azaniumyl]propyl}dimethylsilanolato-κO,κO‘)[(phtalocyaninato(2-)κN29,κN30,κN31,κN32)-1-yl]silicon}oxy)propoxy]carbonyl}amino)hexanoyl (C70H96N11O24S6Si3; molecular weight: 1,752.22)) attached to an average of 2-3 Lys residues of Cetuximab. [2166339-33-7 , Cetuximab sarotalocan] Cetuximab sarotalocan sodium JAPAN 2020/9/25APPROVED AKALUX Antineoplastic セツキシマブサロタロカンナトリウム (遺伝子組換え) Originator Aspyrian Therapeutics Developer Rakuten Medical …

Lactitol, ラクチトール

It’s only fair to share… Lactitol ラクチトール; Formula C12H24O11 CAS 585-86-4 Mol weight 344.3124 To treat chronic idiopathic constipation (CIC) in adults FDA 2/12/2020, APPROVED, Pizensy Lactitol, NS-4, Portolac, Importal Lactitol CAS Registry Number: 585-86-4 CAS Name: 4-O-b-D-Galactopyranosyl-D-glucitol Additional Names: b-galactoside sorbitol; lactit; lactit M; lactite; lactobiosit; lactosit; lactositol Molecular Formula: C12H24O11 Molecular Weight: 344.31 Percent Composition: C 41.86%, H 7.03%, O 51.11% …

Eptinezumab エプチネズマブ;

It’s only fair to share… Eptinezumab エプチネズマブ; (Heavy chain) EVQLVESGGG LVQPGGSLRL SCAVSGIDLS GYYMNWVRQA PGKGLEWVGV IGINGATYYA SWAKGRFTIS RDNSKTTVYL QMNSLRAEDT AVYFCARGDI WGQGTLVTVS SASTKGPSVF PLAPSSKSTS GGTAALGCLV KDYFPEPVTV SWNSGALTSG VHTFPAVLQS SGLYSLSSVV TVPSSSLGTQ TYICNVNHKP SNTKVDARVE PKSCDKTHTC PPCPAPELLG GPSVFLFPPK PKDTLMISRT PEVTCVVVDV SHEDPEVKFN WYVDGVEVHN AKTKPREEQY ASTYRVVSVL TVLHQDWLNG KEYKCKVSNK ALPAPIEKTI SKAKGQPREP QVYTLPPSRE EMTKNQVSLT CLVKGFYPSD IAVEWESNGQ PENNYKTTPP VLDSDGSFFL YSKLTVDKSR WQQGNVFSCS VMHEALHNHY TQKSLSLSPG K (Light …

Teprotumumab-trbw

It’s only fair to share… Tepezza (teprotumumab-trbw) Company: Horizon Therapeutics plc Date of Approval: January 21, 2020 Treatment for: Thyroid Eye Disease Labels for BLA 761143 UNIIY64GQ0KC0A CAS number1036734-93-6 R-1507 / R1507 / RG-1507 / RG1507 / RO-4858696 / RO-4858696-000 / RO-4858696000 / RO4858696 / RO4858696-000 / RV-001 / RV001 Tepezza (teprotumumab-trbw) is a fully human monoclonal antibody (mAb) and a targeted inhibitor of the insulin-like growth factor 1 receptor (IGF-1R) for the treatment of active thyroid eye …