Tag «FDA 2017»

FDA approves first treatment for a form of Batten disease, Brineura (cerliponase alfa)

It’s only fair to share… FDA approves first treatment for a form of Batten disease 04/27/2017 The U.S. Food and Drug Administration today approved Brineura (cerliponase alfa) as a treatment for a specific form of Batten disease. Brineura is the first FDA-approved treatment to slow loss of walking ability (ambulation) in symptomatic pediatric patients 3 …

FDA approves first drug Ingrezza (valbenazine) to treat tardive dyskinesia

It’s only fair to share… Valbenazine Molecular FormulaC24H38N2O4 Average mass418.569 Da (2R,3R,11bR)-3-Isobutyl-9,10-dimethoxy-1,3,4,6,7,11b-hexahydro-2H-pyrido[2,1-a]isoquinolin-2-yl L-valinate (2R,3R,11bR)-9,10-dimethoxy-3-(2-methylpropyl)-1,3,4,6,7,11b-hexahydro-2H-benzo[a]quinolizin-2-yl L-valinate 1025504-45-3 cas L-Valine, (2R,3R,11bR)-1,3,4,6,7,11b-hexahydro-9,10-dimethoxy-3-(2-methylpropyl)-2H-benzo[a]quinolizin-2-yl ester NBI-98854 Valbenazine ditosylate. RN: 1639208-54-0. UNII: 5SML1T733B, Molecular Formula, C24-H38-N2-O4.2C7-H8-O3-S, Molecular Weight, 762.9806 (2R,3R,11bR)-9,10-Dimethoxy-3-(2-methylpropyl)-1,3,4,6,7,11b-hexahydro-2H-benzo(a)quinolizin-2-yl L-valinate bis(4-methylbenzenesulfonate) and Valbenazine dihydrochloride 1639208-51-7 FDA approves first drug to treat tardive dyskinesia 04/11/2017 The U.S. Food and Drug Administration today approved …

FDA approves new eczema drug Dupixent (dupilumab)

It’s only fair to share… FDA approves new eczema drug Dupixent 03/28/2017 The U.S. Food and Drug Administration today approved Dupixent (dupilumab) injection to treat adults with moderate-to-severe eczema (atopic dermatitis). Dupixent is intended for patients whose eczema is not controlled adequately by topical therapies, or those for whom topical therapies are not advisable. Dupixent …

FDA approves first treatment Bavencio (avelumab)for rare form of skin cancer

It’s only fair to share…   Read at……https://www.pfizer.com/files/news/asco/Merck-PfizerAlliance_AvelumabFactSheet_19May2015US.pdf FDA approves first treatment for rare form of skin cancer 03/23/2017 The U.S. Food and Drug Administration today granted accelerated approval to Bavencio (avelumab) for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC), including those who have not …

FDA approves drug Xadago (Safinamide, сафинамид , سافيناميد , 沙非胺 , ) to treat Parkinson’s disease

It’s only fair to share… Safinamide Molecular Formula C17H19FN2O2 Average mass 302.343 Da (2S)-2-[[[4-[(3-Fluorophenyl)methoxy]phenyl]methyl]amino]propanamide 133865-89-1 , сафинамид , سافيناميد ,  沙非胺 ,  EMD-1195686, ZP-034, FCE-28073(R-isomer), PNU-151774E, NW-1015, FCE-26743 CAS   202825-46-5 (mesylate) SEE BELOW (+)-(S)-2-[[p-[(m-fluorobenzyl)oxy]benzyl]amino]propionamide monomethanesulfonate Propanamide, 2-[[[4-[(3-fluorophenyl)methoxy]phenyl]methyl]amino]-, (2S)-, methanesulfonate Molecular Weight 398.45 Formula C17H19FN2O2 ● CH4O3S CAS 202825-46-5 (Safinamide Mesylate) Safinamide is a white to off-white, non-hygroscopic crystalline solid. It shows pH dependent …

Novartis Kisqali® (ribociclib, LEE011) receives FDA approval as first-line treatment for HR+/HER2- metastatic breast cancer in combination with any aromatase inhibitor

It’s only fair to share… Approved based on a first-line Phase III trial that met its primary endpoint of progression-free survival (PFS) at interim analysis due to superior efficacy compared to letrozole alone[1] At this interim analysis, Kisqali plus letrozole reduced risk of disease progression or death by 44% over letrozole alone, and demonstrated tumor …

FDA approves first treatment Noctiva (Desmopressin acetate) nasal spray for frequent urination at night due to overproduction of urine

It’s only fair to share… Desmopressin acetate FDA approves first treatment for frequent urination at night due to overproduction of urine 03/03/2017 The U.S. Food and Drug Administration today approved Noctiva (desmopressin acetate) nasal spray for adults who awaken at least two times per night to urinate due to a condition known as nocturnal polyuria …

FDA approves Odactra for house dust mite allergies

It’s only fair to share… FDA approves Odactra for house dust mite allergies 03/01/2017 The U.S. Food and Drug Administration today approved Odactra, the first allergen extract to be administered under the tongue (sublingually) to treat house dust mite (HDM)-induced nasal inflammation (allergic rhinitis), with or without eye inflammation (conjunctivitis), in people 18 through 65 …

FDA approves Xermelo (telotristat ethyl) for carcinoid syndrome diarrhea

It’s only fair to share…   Telotristat ethyl Molecular Formula, C27-H26-Cl-F3-N6-O3, Molecular Weight, 574.9884, RN: 1033805-22-9 UNII: 8G388563M LX 1032 (2S)-2-Amino-3-[4-[2-amino-6-[[(1R)-1-[4-chloro-2-(3-methylpyrazol-1-yl)phenyl]-2,2,2-trifluoroethyl]oxy]pyrimidin-4-yl]phenyl]propionic acid ethyl ester Ethyl-4-(2-amino-6-{(1R)-1-[4-chlor-2-(3-methyl-1H-pyrazol-1-yl)phenyl]-2,2,2-trifluorethoxy}-4-pyrimidinyl)-L-phenylalaninat L-Phenylalanine, 4-[2-amino-6-[(1R)-1-[4-chloro-2-(3-methyl-1H-pyrazol-1-yl)phenyl]-2,2,2-trifluoroethoxy]-4-pyrimidinyl]-, ethyl ester SEE…………… Telotristat etiprate, (S)-ethyl 2-amino-3-(4-(2-amino-6-((R)-1-(4-chloro-2-(3-methyl-1H-pyrazol-1-yl)phenyl)-2,2,2-trifluoroethoxy)pyrimidin-4-yl)phenyl)propanoate 2-benzamidoacetate . CAS: 1137608-69-5 (etiprate), LX 1606 Chemical Formula: C36H35ClF3N7O6 Molecular Weight: 754.16 L-Phenylalanine, 4-[2-amino-6-[(1R)-1-[4-chloro-2-(3-methyl-1H-pyrazol-1-yl)phenyl]-2,2,2-trifluoroethoxy]-4-pyrimidinyl]-, ethyl ester, compd. with N-benzoylglycine (1:1) LX 1032 …