Category «APPROVALS 2021»

Asparaginase erwinia chrysanthemi (recombinant)-rywn

It’s only fair to share… Sequence: 1ADKLPNIVIL ATGGTIAGSA ATGTQTTGYK AGALGVDTLI NAVPEVKKLA 51NVKGEQFSNM ASENMTGDVV LKLSQRVNEL LARDDVDGVV ITHGTDTVEE 101SAYFLHLTVK SDKPVVFVAA MRPATAISAD GPMNLLEAVR VAGDKQSRGR 151GVMVVLNDRI GSARYITKTN ASTLDTFKAN EEGYLGVIIG NRIYYQNRID 201KLHTTRSVFD VRGLTSLPKV DILYGYQDDP EYLYDAAIQH GVKGIVYAGM 251GAGSVSVRGI AGMRKAMEKG VVVIRSTRTG NGIVPPDEEL PGLVSDSLNP 301AHARILLMLA LTRTSDPKVI QEYFHTY >Protein sequence for asparaginase (Erwinia chrysanthemi) monomer ADKLPNIVILATGGTIAGSAATGTQTTGYKAGALGVDTLINAVPEVKKLANVKGEQFSNM ASENMTGDVVLKLSQRVNELLARDDVDGVVITHGTDTVEESAYFLHLTVKSDKPVVFVAA MRPATAISADGPMNLLEAVRVAGDKQSRGRGVMVVLNDRIGSARYITKTNASTLDTFKAN EEGYLGVIIGNRIYYQNRIDKLHTTRSVFDVRGLTSLPKVDILYGYQDDPEYLYDAAIQH GVKGIVYAGMGAGSVSVRGIAGMRKAMEKGVVVIRSTRTGNGIVPPDEELPGLVSDSLNP AHARILLMLALTRTSDPKVIQEYFHTY References: Therapeutic Targets …

Tralokinumab

It’s only fair to share… (Heavy chain) QVQLVQSGAE VKKPGASVKV SCKASGYTFT NYGLSWVRQA PGQGLEWMGW ISANNGDTNY GQEFQGRVTM TTDTSTSTAY MELRSLRSDD TAVYYCARDS SSSWARWFFD LWGRGTLVTV SSASTKGPSV FPLAPCSRST SESTAALGCL VKDYFPEPVT VSWNSGALTS GVHTFPAVLQ SSGLYSLSSV VTVPSSSLGT KTYTCNVDHK PSNTKVDKRV ESKYGPPCPS CPAPEFLGGP SVFLFPPKPK DTLMISRTPE VTCVVVDVSQ EDPEVQFNWY VDGVEVHNAK TKPREEQFNS TYRVVSVLTV LHQDWLNGKE YKCKVSNKGL PSSIEKTISK AKGQPREPQV YTLPPSQEEM TKNQVSLTCL VKGFYPSDIA VEWESNGQPE NNYKTTPPVL DSDGSFFLYS RLTVDKSRWQ EGNVFSCSVM HEALHNHYTQ KSLSLSLGK (Light chain) SYVLTQPPSV …

Upacicalcet sodium hydrate

It’s only fair to share…   Upacicalcet sodium hydrate, ウパシカルセトナトリウム水和物 CAS 2052969-18-1 1333218-50-0 free PMDA JAPAN APPROVED 2021/6/23, Upasita Calcium sensing receptor agonist (2S)-2-amino-3-[(3-chloro-2-methyl-5-sulfophenyl)carbamoylamino]propanoic acid Formula C11H13ClN3O6S. Na. xH2O   OriginatorAjinomoto Pharma DeveloperSanwa Kagaku Kenkyusho ClassAmines; Chlorobenzenes; Propionic acids; Small molecules; Sulfonic acids; Toluenes Mechanism of ActionCalcium-sensing receptor agonists RegisteredSecondary hyperparathyroidism 25 Jun 2021Chemical structure information added 23 Jun …

Imeglimin hydrochloride

It’s only fair to share… Meglimin hydrochloride Twymeeg Formula C6H13N5. HCl CAS 775351-61-6 (HCl). , C6H14ClN5 191.66 CAS 775351-65-0, FREEFORM 155.20 Mol weight 191.6619   AntidiabeticAPPROVED PMDA JAPAN2021/6/23, イメグリミン塩酸塩 (4R)-6-N,6-N,4-trimethyl-1,4-dihydro-1,3,5-triazine-2,6-diamine DB12509 NCGC00378621-02 HY-14771 Q6003719 UNII-UU226QGU97 UU226QGU97 1,3,5-Triazine-2,4-diamine,1,6-dihydro-N,N,6-trimethyl-,(+)-(9CI) (4R)-6-N,6-N,4-trimethyl-1,4-dihydro-1,3,5-triazine-2,6-diamine Imeglimin [INN] Emd 387008 (R-imeglimin) HCl EMD-387008 Imeglimin is an experimental drug being developed as an oral anti-diabetic.[1][2] It is an oxidative phosphorylation blocker that …

Tucidinostat, Chidamide

It’s only fair to share…   Tucidinostat, Chidamide ツシジノスタット 2021/6/23 PMDA JAPAN APPROVED, Hiyasta Formula C22H19FN4O2 CAS 1616493-44-7 Mol weight 390.4103 Antineoplastic, Histone deacetylase inhibitor Chidamide (Epidaza) is a histone deacetylase inhibitor (HDI) developed in China.[1] It was also known as HBI-8000.[2] It is a benzamide HDI and inhibits Class I HDAC1, HDAC2, HDAC3, as well as Class IIb HDAC10.[3] Chidamide is approved by the Chinese FDA for …

ZF 2001, ZIFIVAX

It’s only fair to share… Republic of Uzbekistan Oʻzbekiston Respublikasi  (Uzbek) Flag State emblem ZF2001 ZIFIVAX CAS 2609662-31-7 A COVID-19 vaccine comprising a dimeric form of SARS-CoV-2 receptor-binding domain (RBD) produced in China hamster ovary (CHO) cells and adjuvanted with aluminum hydroxide (Anhui Zhifei Longcom/Institute of Microbiol. China Academy of Sciences) Recombinant vaccine Anhui Zhifei Longcom Biopharmaceutical, …

Estetrol

It’s only fair to share… Estetrol エステトロール; Formula C18H24O4 CAS 15183-37-6 Mol weight 304.3808 FDA 4/15/2021, To prevent pregnancy, Nextstellis New Drug Application (NDA): 214154 Company: MAYNE PHARMA Label (PDF) Letter (PDF) Review Label (PDF) PATENT https://patents.google.com/patent/EP1562976B1/en Estrogenic substances are commonly used in methods of Hormone Replacement Therapy (HRT) and methods of female contraception. These estrogenic substances can be …

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 …