Category «FDA 2021»

Plasminogen

It’s only fair to share…   Plasminogen FDA  APPROVED 2021, Ryplazim, 2021/6/4 Plasminogen; Glu-plasminogen; Plasminogen, human-tvmh; Ryplazim (TN) RYPLAZIM (plasminogen, human-tvmh) Enzyme replacement (plasminogen), Plasminogen deficiency type 1 CAS: 9001-91-6 STN: 125659 Proper Name: plasminogen, human-tvmh Tradename: RYPLAZIM Manufacturer: Prometic Biotherapeutics Inc. Indication: For the treatment of patients with plasminogen deficiency type 1 (hypoplasminogenemia) READ  https://diapharma.com/plasminogen-plg/ On August 11, 2017 Prometic Biotherapeutics submitted a …

Difelikefalin acetate

It’s only fair to share…   Difelikefalin acetate ジフェリケファリン酢酸塩 CAS 1024829-44-4 Formula C36H53N7O6. (C2H4O2)x D-Phe-D-Phe-D-Leu-D-Lys-[ω(4-aminopiperidine-4- carboxylic acid)]-OH FDA APPROVED, 2021/8/23, FORSUVA Analgesic, Antipruritic, Opioid receptor agonist Treatment of moderate-to-severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis Difelikefalin, CR-845; MR-13A-9; MR-13A9 4-amino-1- (D-phenylalanyl-D-phenylalanyl-D-leucyl-D-lysyl) piperidine-4-carboxylic acid C36H53N7O6, 679.40573 ORIGINATOR Ferring Pharmaceuticals DEVELOPER Cara Therapeutics CLASS Analgesic …

Lonapegsomatropin

It’s only fair to share… FPTIPLSRLF DNAMLRAHRL HQLAFDTYQE FEEAYIPKEQ KYSFLQNPQT SLCFSESIPT PSNREETQQK SNLELLRISL LLIQSWLEPV QFLRSVFANS LVYGASDSNV YDLLKDLEEG IQTLMGRLED GSPRTGQIFK QTYSKFDTNS HNDDALLKNY GLLYCFRKDM DKVETFLRIV QCRSVEGSCG F (Disulfide bridge: 53-165, 182-189) Lonapegsomatropin, ロナペグソマトロピン FDA APPROVED, 25/8/21, Skytrofa, Treatment of growth hormone deficiency To treat short stature due to inadequate secretion of endogenous growth hormone 1934255-39-6 CAS, UNII: OP35X9610Y Molecular Formula, C1051-H1627-N269-O317-S9[-C2-H4-O]4n ACP 001; …

Belzutifan

It’s only fair to share… Belzutifan CAS 1672668-24-4 383.34 g·mol−1  C17H12F3NO4S 3-[[(1S,2S,3R)-2,3-difluoro-1-hydroxy-7-methylsulfonyl-2,3-dihydro-1H-inden-4-yl]oxy]-5-fluorobenzonitrile MK-6482, PT-2977, UNII-7K28NB895L, 7K28NB895L 3-[(1S,2S,3R)-2,3-Difluoro-1-hydroxy-7-methylsulfonylindan-4-yl]oxy-5-fluorobenzonitrile 3-{[(1s,2s,3r)-2,3-Difluoro-1-Hydroxy-7-(Methylsulfonyl)-2,3-Dihydro-1h-Inden-4-Yl]oxy}-5-Fluorobenzonitrile GTPL11251, PT 2977 [WHO-DD], BDBM373040 FDA APPROVED 8/13/2021, Welireg To treat von Hippel-Lindau disease under certain conditions EMA Drug Information Disease/Condition Treatment of von Hippel-Lindau disease Active Substance 3-(((1S,2S,3R)-2,3-difluoro-1-hydroxy-7-(methylsulfonyl)-2,3-dihydro-1H-inden-4-yl)oxy)-5-fluorobenzonitrile Status of Orphan Designation Positive Decision Date 2020-08-21 FDA approves belzutifan for cancers associated with von Hippel-Lindau disease On …

Avalglucosidase alfa

It’s only fair to share… QQGASRPGPR DAQAHPGRPR AVPTQCDVPP NSRFDCAPDK AITQEQCEAR GCCYIPAKQG LQGAQMGQPW CFFPPSYPSY KLENLSSSEM GYTATLTRTT PTFFPKDILT LRLDVMMETE NRLHFTIKDP ANRRYEVPLE TPRVHSRAPS PLYSVEFSEE PFGVIVHRQL DGRVLLNTTV APLFFADQFL QLSTSLPSQY ITGLAEHLSP LMLSTSWTRI TLWNRDLAPT PGANLYGSHP FYLALEDGGS AHGVFLLNSN AMDVVLQPSP ALSWRSTGGI LDVYIFLGPE PKSVVQQYLD VVGYPFMPPY WGLGFHLCRW GYSSTAITRQ VVENMTRAHF PLDVQWNDLD YMDSRRDFTF NKDGFRDFPA MVQELHQGGR RYMMIVDPAI SSSGPAGSYR PYDEGLRRGV FITNETGQPL IGKVWPGSTA FPDFTNPTAL AWWEDMVAEF HDQVPFDGMW IDMNEPSNFI RGSEDGCPNN ELENPPYVPG VVGGTLQAAT …

Anifrolumab

It’s only fair to share… (Heavy chain) EVQLVQSGAE VKKPGESLKI SCKGSGYIFT NYWIAWVRQM PGKGLESMGI IYPGDSDIRY SPSFQGQVTI SADKSITTAY LQWSSLKASD TAMYYCARHD IEGFDYWGRG TLVTVSSAST KGPSVFPLAP SSKSTSGGTA ALGCLVKDYF PEPVTVSWNS GALTSGVHTF PAVLQSSGLY SLSSVVTVPS SSLGTQTYIC NVNHKPSNTK VDKRVEPKSC DKTHTCPPCP APEFEGGPSV FLFPPKPKDT LMISRTPEVT CVVVDVSHED PEVKFNWYVD GVEVHNAKTK PREEQYNSTY RVVSVLTVLH QDWLNGKEYK CKVSNKALPA SIEKTISKAK GQPREPQVYT LPPSREEMTK NQVSLTCLVK GFYPSDIAVE WESNGQPENN YKTTPPVLDS DGSFFLYSKL TVDKSRWQQG NVFSCSVMHE ALHNHYTQKS LSLSPGK (Lihgt chain) EIVLTQSPGT …

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 …

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 …