Category «FDA 2017»

FDA approves new eczema drug Dupixent (dupilumab)

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 can be used with or …

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

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 received prior chemotherapy. This is …

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

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 solubility in aqueous buffers due …

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

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 burden reduction with a 53% …

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

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 (overproduction of urine during the …

Oxymetazoline, оксиметазолин , أوكسيميتازولين , 羟甲唑啉

Oxymetazoline 1491-59-4 CAS NUMBER Molecular FormulaC16H24N2O Average mass260.375 Da Phenol, 3-[(4,5-dihydro-1H-imidazol-2-yl)methyl]-6-(1,1-dimethylethyl)-2,4-dimethyl- оксиметазолин أوكسيميتازولين 羟甲唑啉 Oxymetazoline is a selective α1 adrenergic receptor agonist and α2 adrenergic receptor partial agonist. It is a topical decongestant, used in the form of oxymetazoline hydrochloride. It was developed from xylometazoline at E. Merck Darmstadt by Fruhstorfer in 1961.[1] Oxymetazoline is …

FDA approves Odactra for house dust mite allergies

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 years of age. March 1, …

FDA approves Xermelo (telotristat ethyl) for carcinoid syndrome diarrhea

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 hippurate LX 1606 SEE ALSO…………. …

Deflazacort

Deflazacort CAS 14484-47-0 Molecular Formula C25H31NO6 Average mass 441.517 Da (11b,16b)-21-(Acetyloxy)-11-hydroxy-2′-methyl-5’H-pregna-1,4-dieno[17,16-d]oxazole-3,20-dione 11b,21-Dihydroxy-2′-methyl-5’bH-pregna-1,4-dieno[17,16-d]oxazole-3,20-dione 21-acetate 2-[(4aR,4bS,5S,6aS,6bS,9aR,10aS,10bS)-5-Hydroxy-4a,6a,8-trimethyl-2-oxo-2,4a,4b,5,6,6a,9a,10,10a,10b,11,12-dodecahydro-6bH-naphtho[2′,1′:4,5]indeno[1,2-d][1,3]oxazol-6b-yl]-2-oxoethyl acetate 5’βH-Pregna-1,4-dieno[17,16-d]oxazole-3,20-dione, 11β,21-dihydroxy-2′-methyl-, 21-acetate (8CI) (11β,16β)-21-(Acetyloxy)-11-hydroxy-2′-methyl-5’H-pregna-1,4-dieno[17,16-d]oxazole-3,20-dione 2H-Naphth[2′,1′:4,5]indeno[1,2-d]oxazole, 5’H-pregna-1,4-dieno[17,16-d]oxazole-3,20-dione deriv. Azacort Azacortinol Calcort DL 458IT Deflan Optical Rotatory Power +62.3 ° Conc: 0.5 g/100mL; Solv: chloroform (67-66-3); Wavlength: 589.3 nm …………..REF, “Drugs – Synonyms and Properties” data were obtained from Ashgate Publishing Co. (US)Hoechst …