Tag «fda 2019»

FDA approves novel treatment Oxbryta (voxelotor) to target abnormality in sickle cell disease

It’s only fair to share… Today, the U.S. Food and Drug Administration granted accelerated approval to Oxbryta (voxelotor) for the treatment of sickle cell disease (SCD) in adults and pediatric patients 12 years of age and older. “Today’s approval provides additional hope to the 100,000 people in the U.S., and the more than 20 million …

FDA approves new treatment XCOPRI (cenobamate tablets) for adults with partial-onset seizures

It’s only fair to share… The U.S. Food and Drug Administration today approved XCOPRI (cenobamate tablets) to treat partial-onset seizures in adults. “XCOPRI is a new option to treat adults with partial-onset seizures, which is an often difficult-to-control condition that can have a significant impact on patient quality of life,” said Billy Dunn, M.D., director …

FDA approves first treatment Givlaari (givosiran) for inherited rare disease

It’s only fair to share… Today, the U.S. Food and Drug Administration granted approval to Givlaari (givosiran) for the treatment of adult patients with acute hepatic porphyria, a genetic disorder resulting in the buildup of toxic porphyrin molecules which are formed during the production of heme (which helps bind oxygen in the blood). “This buildup …

Afamelanotide, アファメラノチド , афамеланотид , أفاميلانوتيد , 阿法诺肽 ,

It’s only fair to share… Afamelanotide RN: 75921-69-6 Molecular Formula, C78-H111-N21-O19, Molecular Weight, 1646.8629 Synonyms 75921-69-6 AFAMELANOTIDE [MI] AFAMELANOTIDE AFAMELANOTIDE [INN] .ALPHA.-MELANOTROPIN (SWINE), 4-L-NORLEUCINE-7-D-PHENYLALANINE- AC-SER-TYR-SER-NLE-GLU-HIS-D-PHE-ARG-TRP-GLY-LYS-PRO-VAL-NH2 CUV1647 AFAMELANOTIDE [WHO-DD] AFAMELANOTIDE [USAN] ACETYL(4-(2S)-2-AMINOHEXANOIC ACID,7-D-PHENYLALANINE)HUMAN MELANOTROPIN ALPHA CUV-1647 MELANOTAN I MELANOTAN-1 alpha-Melanotropin, 4-L-norleucine-7-D-phenylalanine- Prevention of Phototoxicity in Adults with Erythropoietic Protoporphyria (EPP) UNII: QW68W3J66U アファメラノチド; афамеланотид [Russian] [INN] أفاميلانوتيد [Arabic] [INN] 阿法诺肽 [Chinese] [INN] Observations suggest …

Edotreotide gallium Ga-68

It’s only fair to share…     Edotreotide gallium Ga-68 エドトレオチドガリウム (68Ga); Edotreotide Gallium Ga-68 Gallium (68Ga) edotreotide Gallium edotreotide Ga-68 Gallium Ga 68-dotatoc Gallium Ga 68-edotreotide Gallium Ga-68 edotreotide gallium;2-[4-[2-[[(2R)-1-[[(4R,7S,10S,13R,16S,19R)-10-(4-aminobutyl)-4-[[(1S,2R)-1-carboxy-2-hydroxypropyl]carbamoyl]-7-[(1R)-1-hydroxyethyl]-16-[(4-hydroxyphenyl)methyl]-13-(1H-indol-3-ylmethyl)-6,9,12,15,18-pentaoxo-1,2-dithia-5,8,11,14,17-pentazacycloicos-19-yl]amino]-1-oxo-3-phenylpropan-2-yl]amino]-2-oxoethyl]-7,10-bis(carboxylatomethyl)-1,4,7,10-tetrazacyclododec-1-yl]acetate L-threonine, N-[[(4R,7S,10S,13R,16S,19R)-10-(4-aminobutyl)-7-[(1R)-1-hydroxyethyl]-16-[(4-hydroxyphenyl)methyl]-13-(1H-indol-3-ylmethyl)-6,9,12,15,18-pentaoxo-19-[[(2R)-1-oxo-3-phenyl-2-[[2-[4,7,10-tris(carboxymethyl)-1,4,7,10-tetraazacyclododec-1-yl]acetyl]amino]propyl]amino]-1,2-dithia-5,8,11,14,17-pentaazacycloeicos-4-yl]carbonyl]-, gallium salt (1:1) 2,2′,2”-[10-(2-{[(2R)-1-{[(4R,7S,10S,13R,16S,19R)-10-(4-Aminobutyl)-4-{[(1S,2R)-1-carboxy-2-hydroxypropyl]carbamoyl}-16-(4-hydroxybenzyl)-7-[(1R)-1-hydroxyéthyl]-13-(1H-indol-3-ylméthyl)-6,9,12,15,18 -pentaoxo-1,2-dithia-5,8,11,14,17-pentaazacycloicosan-19-yl]amino}-1-oxo-3-phényl-2-propanyl]amino}-2-oxoéthyl)-1,4,7,10-tétraazacyclododécane-1,4,7-triyl]triacétate de gallium Gallium 2,2′,2”-[10-(2-{[(2R)-1-{[(4R,7S,10S,13R,16S,19R)-10-(4-aminobutyl)-4-{[(1S,2R)-1-carboxy-2-hydroxypropyl]carbamoyl}-16-(4-hydroxybenzyl)-7-[(1R)-1-hydroxyethyl]-13-(1H-indol-3-ylmethyl)-6,9, 12,15,18-pentaoxo-1,2-dithia-5,8,11,14,17-pentaazacycloicosan-19-yl]amino}-1-oxo-3-phenyl-2-propanyl]amino}-2-oxoethyl)-1,4,7,10-tetraazacyclododecane-1,4,7-triyl]triacetate gallium 2,2′,2”-[10-(2-{[(2R)-1-{[(4R,7S,10S,13R,16S,19R)-10-(4-aminobutyl)-4-{[(1S,2R)-1-carboxy-2-hydroxypropyl]carbamoyl}-16-(4-hydroxybenzyl)-7-[(1R)-1-hydroxyethyl]-13-(1H-indol-3-ylmethyl)-6,9,12,15,18-pentaoxo-1,2-dithia-5,8,11,14,17-pentaazacycloicosan-19-yl]amino}-1-oxo-3-phenylpropan-2-yl]amino}-2-oxoethyl)-1,4,7,10-tetraazacyclododecane-1,4,7-triyl]triacetate L-Threonine, N-[[(4R,7S,10S,13R,16S,19R)-10-(4-aminobutyl)-7-[(1R)-1-hydroxyethyl]-16-[(4-hydroxyphenyl)methyl]-13-(1H-indol-3-ylmethyl)-6,9,12,15,18-pentaoxo-19-[[(2R)-1-oxo-3-phenyl-2-[[2-[4,7,10-tr is(carboxymethyl)-1,4,7,10-tetraazacyclododec-1-yl]acetyl]amino]propyl]amino]-1,2-dithia-5,8,11,14,17-pentaazacycloeicos-4-yl]carbonyl]-, gallium salt (1:1) L-threonine, N-[[(4R,7S,10S,13R,16S,19R)-10-(4-aminobutyl)-7-[(1R)-1-hydroxyethyl]-16-[(4-hydroxyphenyl)methyl]-13-(1H-indol-3-ylmethyl)-6,9,12,15,18-pentaoxo-19-[[(2R)-1-oxo-3-phenyl-2-[[2-[4,7,10-tris(carboxymethyl)-1,4,7,10-tetraazacyclododec-1-yl]acetyl]amino]propyl]amino]-1,2-dithia-5,8,11,14,17-pentaazacycloeicos-4-yl]carbonyl]-, gallium salt …

Cilastatin, циластатин , سيلاستاتين , 西司他丁 ,

It’s only fair to share… Cilastatin シラスタチン циластатин [Russian] [INN] سيلاستاتين [Arabic] [INN] 西司他丁 [Chinese] [INN] UNII141A6AMN38 CAS number 82009-34-5 WeightAverage: 358.453 Monoisotopic: 358.156242642 Chemical FormulaC16H26N2O5S (L)-7-(2-Amino-2-carboxy-ethylsulfanyl)-2-[(2,2-dimethyl-cyclopropanecarbonyl)-amino]-hept-2-enoic acid (Z)-(S)-6-carboxy-6-[(S)-2,2-dimethylcyclopropanecarboxamido]hex-5-enyl-L-cysteine (Z)-7-((R)-2-Amino-2-carboxy-ethylsulfanyl)-2-[((S)-2,2-dimethyl-cyclopropanecarbonyl)-amino]-hept-2-enoic acid (2Z)-7-{[(2R)-2-amino-2-carboxyethyl]sulfanyl}-2-{[(1S)-2,2-dimethylcyclopropyl]formamido}hept-2-enoic acid MK 0791|Primaxin® Primaxin® TL8005438 UNII:141A6AMN38 UNII-141A6AMN38 EINECS 279-875-8  Cilastatin CAS Registry Number: 82009-34-5 CAS Name: (2Z)-7-[[(2R)-2-Amino-2-carboxyethyl]thio]-2-[[[(1S)-2,2-dimethylcyclopropyl]carbonyl]amino]-2-heptenoic acid Manufacturers’ Codes: MK-791 Molecular Formula: C16H26N2O5S Molecular Weight: 358.45 Percent Composition: C 53.61%, H 7.31%, N 7.82%, …

FDA approves first treatment Dupixent (Dupilumab) for chronic rhinosinusitis with nasal polyps

It’s only fair to share… The U.S. Food and Drug Administration today approved Dupixent (dupilumab) to treat adults with nasal polyps (growths on the inner lining of the sinuses) accompanied by chronic rhinosinusitis (prolonged inflammation of the sinuses and nasal cavity). This is the first treatment approved for inadequately controlled chronic rhinosinusis with nasal polyps. …

FDA approves first treatment Soliris (eculizumab) for neuromyelitis optica spectrum disorder, a rare autoimmune disease of the central nervous system

It’s only fair to share… The U.S. Food and Drug Administration today approved Soliris (eculizumab) injection for intravenous use for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. NMOSD is an autoimmune disease of the central nervous system that mainly affects the optic nerves and spinal …

FDA approves new add-on drug Nourianz (istradefylline) to treat off episodes in adults with Parkinson’s disease

It’s only fair to share… READ AT https://newdrugapprovals.org/2016/04/25/istradefylline/ FDA approves new add-on drug  Nourianz (istradefylline)  to treat off episodes in adults with Parkinson’s disease The U.S. Food and Drug Administration today approved Nourianz (istradefylline) tablets as an add-on treatment to levodopa/carbidopa in adult patients with Parkinson’s disease (PD) experiencing “off” episodes. An “off” episode is a …

FDA approves treatment Inrebic (fedratinib) for patients with rare bone marrow disorder

It’s only fair to share… FDA approves treatment Inrebic (fedratinib) for patients with rare bone marrow disorder Today, the U.S. Food and Drug Administration approved Inrebic (fedratinib) capsules to treat adult patients with certain types of myelofibrosis. “Prior to today, there was one FDA-approved drug to treat patients with myelofibrosis, a rare bone marrow disorder. …