Category «FDA 2019»

FDA approves first treatment Benlysta (belimumab) for pediatric patients with lupus

The U.S. Food and Drug Administration today approved Benlysta (belimumab) intravenous (IV) infusion for treatment of children with systemic lupus erythematosus (SLE) – often referred to as simply “lupus” – a serious chronic disease that causes inflammation and damage to various body tissues and organs. This is the first time that the FDA has …

Solriamfetol hydrochloride, ソルリアムフェトル塩酸塩 , солриамфетол , سولريامفيتول , 索安非托 ,

Solriamfetol hydrochloride FDA APPROVED 2019/3/20, Sunosi ソルリアムフェトル塩酸塩; R228060, R 228060 Formula C10H14N2O2. HCl CAS 178429-65-7 HCL Mol weight 230.6913 (2R)-2-Amino-3-phenylpropyl carbamate (2R)-2-Amino-3-phenylpropylcarbamat 10117 178429-62-4 [RN] FREE FORM Benzenepropanol, β-amino-, carbamate (ester), (βR)- [ солриамфетол [Russian] [INN] سولريامفيتول [Arabic] [INN] 索安非托 [Chinese] [INN] JZP-110 Originator SK Holdings Developer Jazz Pharmaceuticals plc; SK biopharmaceuticals Class Carbamates; Sleep disorder therapies; Small molecules Mechanism of Action Adrenergic uptake inhibitors; Dopamine uptake inhibitors Orphan Drug Status Yes – …

Certolizumab pegol, セルトリズマブペゴル (遺伝子組換え)

>Amino acid sequence of the light chain DIQMTQSPSSLSASVGDRVTITCKASQNVGTNVAWYQQKPGKAPKALIYSASFLYSGVPY RFSGSGSGTDFTLTISSLQPEDFATYYCQQYNIYPLTFGQGTKVEIKRTVAAPSVFIFPP SDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLT LSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC >Amino acid sequence of the heavy chain EVQLVESGGGLVQPGGSLRLSCAASGYVFTDYGMNWVRQAPGKGLEWMGWINTYIGEPIY ADSVKGRFTFSLDTSKSTAYLQMNSLRAEDTAVYYCARGYRSYAMDYWGQGTLVTVSSAS TKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGL YSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCAA Certolizumab pegol CAS: 428863-50-7 セルトリズマブペゴル (遺伝子組換え) CDP 870 / CDP-870 / CDP870 / PHA-738144 Formula C2115H3252N556O673S16 Cas 428863-50-7 Mol weight 47748.8128 Reducing signs and symptoms of Crohn’s disease and treatment of moderately to severely active rheumatoid arthritis (RA). Certolizumab …

FDA approves new oral testosterone capsule for treatment of men with certain forms of hypogonadism

FDA approves new oral testosterone capsule (testosterone undecanoate) for treatment of men with certain forms of hypogonadism March 27, 2019 Release The U.S. Food and Drug Administration today approved Jatenzo (testosterone undecanoate), an oral testosterone capsule to treat men with certain forms of hypogonadism. These men have low testosterone levels due to specific medical …

ブレキサノロン , Brexanolone, Allopregnanolone

Brexanolone 318.501 g/mol, C21H34O2 CAS: 516-54-1 ブレキサノロン MFCD00003677 Pregnan-20-one, 3-hydroxy-, (3α,5α)- Pregnan-20-one, 3-hydroxy-, (3α,5α)- [ACD/Index Name] S39XZ5QV8Y TU4383000 UNII:S39XZ5QV8Y (1S,2S,7S,11S,14S,15S,5R,10R)-14-acetyl-5-hydroxy-2,15-dimethyltetracyclo[8.7.0.0<2,7>.0<11,15>]heptadecane (+)-3a-Hydroxy-5a-pregnan-20-one (+)-3α-Hydroxy-5α-pregnan-20-one (3α,5α)-3-Hydroxypregnan-20-one [ACD/IUPAC Name] 10446 3211363 [Beilstein] 3a-Hydroxy-5a-pregnan-20-one The U.S. Food and Drug Administration today approved Zulresso (brexanolone) injection for intravenous (IV) use for the treatment of postpartum depression (PPD) in adult women. This is the first drug …

Prabotulinumtoxin A, プラボツリナムトキシンA

>Botulinum Toxin Type A Sequence MPFVNKQFNYKDPVNGVDIAYIKIPNVGQMQPVKAFKIHNKIWVIPERDTFTNPEEGDLN PPPEAKQVPVSYYDSTYLSTDNEKDNYLKGVTKLFERIYSTDLGRMLLTSIVRGIPFWGG STIDTELKVIDTNCINVIQPDGSYRSEELNLVIIGPSADIIQFECKSFGHEVLNLTRNGY GSTQYIRFSPDFTFGFEESLEVDTNPLLGAGKFATDPAVTLAHELIHAGHRLYGIAINPN RVFKVNTNAYYEMSGLEVSFEELRTFGGHDAKFIDSLQENEFRLYYYNKFKDIASTLNKA KSIVGTTASLQYMKNVFKEKYLLSEDTSGKFSVDKLKFDKLYKMLTEIYTEDNFVKFFKV LNRKTYLNFDKAVFKINIVPKVNYTIYDGFNLRNTNLAANFNGQNTEINNMNFTKLKNFT GLFEFYKLLCVRGIITSKTKSLDKGYNKALNDLCIKVNNWDLFFSPSEDNFTNDLNKGEE ITSDTNIEAAEENISLDLIQQYYLTFNFDNEPENISIENLSSDIIGQLELMPNIERFPNG KKYELDKYTMFHYLRAQEFEHGKSRIALTNSVNEALLNPSRVYTFFSSDYVKKVNKATEA AMFLGWVEQLVYDFTDETSEVSTTDKIADITIIIPYIGPALNIGNMLYKDDFVGALIFSG AVILLEFIPEIAIPVLGTFALVSYIANKVLTVQTIDNALSKRNEKWDEVYKYIVTNWLAK VNTQIDLIRKKMKEALENQAEATKAIINYQYNQYTEEEKNNINFNIDDLSSKLNESINKA MININKFLNQCSVSYLMNSMIPYGVKRLEDFDASLKDALLKYIYDNRGTLIGQVDRLKDK VNNTLSTDIPFQLSKYVDNQRLLSTFTEYIKNIINTSILNLRYESNHLIDLSRYASKINI GSKVNFDPIDKNQIQLFNLESSKIEVILKNAIVYNSMYENFSTSFWIRIPKYFNSISLNN EYTIINCMENNSGWKVSLNYGEIIWTLQDTQEIKQRVVFKYSQMINISDYINRWIFVTIT NNRLNNSKIYINGRLIDQKPISNLGNIHASNNIMFKLDGCRDTHRYIWIKYFNLFDKELN EKEIKDLYDNQSNSGILKDFWGDYLQYDKPYYMLNLYDPNKYVDVNNVGIRGYMYLKGPR GSVMTTNIYLNSSLYRGTKFIIKKYASGNKDNIVRNNDRVYINVVVKNKEYRLATNASQA GVEKILSALEIPDVGNLSQVVVMKSKNDQGITNKCKMNLQDNNGNDIGFIGFHQFNNIAK LVASNWYNRQIERSSRTLGCSWEFIPVDDGWGERPL Prabotulinumtoxin A プラボツリナムトキシンA; Formula C6760H10447N1743O2010S32 CAS 93384-43-1 Mol weight 149320.8333 AGN 191622 / ANT-1207 / ANT-1401 / ANT-1403 / NT 201 APPROVED , FDA 2019, Jeuveau, 2019/2/1 Purified botulinum toxin from Clostridium botulinum, purified from culture via dialysis …

Triclabendazole, トリクラベンダゾール

Triclabendazole トリクラベンダゾール CGA-89317 Formula C14H9Cl3N2OS CAS 68786-66-3 Mol weight 359.6581 Anthelmintic 5-Chloro-6-(2,3-dichlorophenoxy)-2-methylthio-1H-benzimidazole 68786-66-3 [RN] DD6747000 Fasinex [Trade name] MFCD00864519 [MDL number] APPROVED, Egat, FDA 2019, 02/13/2019 Triclabendazole, sold under the brand name Egaten among others, is a medication used to treat liver flukes, specifically fascioliasisand paragonimiasis.[1] It is very effective for both conditions.[1] Treatment in hospital may be required.[1] It is taken by mouth with typically …

Caplacizumab-yhdp, カプラシズマブ

FDA approves first therapy Cablivi (caplacizumab-yhdp) カプラシズマブ , for the treatment of adult patients with a rare blood clotting disorder FDA February 6, 2019 Release https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm630851.htm?utm_campaign=020919_PR_FDA%20approves%20therapy%20for%20treatment%20of%20adult%20patients%20with%20rare%20blood%20clotting%20disorder&utm_medium=email&utm_source=Eloqua The U.S. Food and Drug Administration today approved Cablivi (caplacizumab-yhdp) injection, the first therapy specifically indicated, in combination with plasma exchange and immunosuppressive therapy, for the treatment of adult …

Ferric Maltol, マルトール第二鉄

Ferric Maltol Iron, tris(3-hydroxy-2-methyl-4H-pyran-4-onato-O3,O4)- Molecular Formula: C18H15FeO9 Molecular Weight: 431.154 g/mol iron(3+);2-methyl-4-oxopyran-3-olate RN: 33725-54-1 UNII: MA10QYF1Z0 Feraccru Ferric maltol; UNII-MA10QYF1Z0; MA10QYF1Z0; Ferric maltol (INN); Ferric maltol [INN]; 33725-54-1 Shield Therapeutics, under license from Vitra Pharmaceuticals UPDATE Originator University of Cambridge; University of London Developer Shield Therapeutics Class Antianaemics; Ferric compounds; Pyrones; Small molecules Mechanism of Action Iron replacements Marketed Iron deficiency anaemia …

LASMIDITAN

LASMIDITAN, COL-144 , LY-573144 Molecular FormulaC19H18F3N3O2 Average mass377.360 Da ласмидитан لاسميديتان 613677-28-4 HYDROCHLORIDE 439239-90-4 (free base) SUCCINATE 439239-92-6 2,4,6-Trifluoro-N-[6-(1-methylpiperidin-4-ylcarbonyl)pyridin-2-yl]benzamide 2,4,6-trifluoro-N-{6-[(1-methylpiperidin-4-yl)carbonyl]pyridin-2-yl}benzamide CoLucid Pharmaceuticals, PHASE 3, MIGRAINE UNII:760I9WM792 Lasmiditan is an oral medication used in the termination of migraine headaches that was first approved for use in the United States in October 2019. A high-affinity, highly selective serotonin 5-HT(1F) …