Category «FDA 2017»

Secnidazole, секнидазол , سيكنيدازول , 塞克硝唑 ,

It’s only fair to share…   Secnidazole Molecular FormulaC7H11N3O3 Average mass185.180 Da 1-(2-Methyl-5-nitroimidazol-1-yl)-2-propanol 1H-Imidazole-1-ethanol, α,2-dimethyl-5-nitro- [ACD/Index Name] 222-134-0 [EINECS] 3366-95-8 [RN] a,2-Dimethyl-5-nitro-1H-imidazole-1-ethanol UNII:R3459K699K секнидазол[Russian][INN] سيكنيدازول[Arabic][INN] 塞克硝唑[Chinese][INN] RP-14539, PM-185184, Flagentyl Company: Symbiomix Therapeutics Approval Status: Approved FDA September 2017 Specific Treatments: bacterial vaginosis Therapeutic Areas Obstetrics/Gynecology (Women’s Health) Infections and Infectious Diseases Solosec (secnidazole) ; Symbiomix Therapeutics; For the treatment of bacterial vaginosis , …

FDA approves CAR-T cell therapy Yescarta (axicabtagene ciloleucel) to treat adults with certain types of large B-cell lymphoma

It’s only fair to share… FDA approves CAR-T cell therapy to treat adults with certain types of large B-cell lymphoma Yescarta is the second gene therapy product approval in the U.S. The U.S. Food and Drug Administration today approved Yescarta (axicabtagene ciloleucel), a cell-based gene therapy, to treat adult patients with certain types of large …

FDA approves new treatment for certain advanced or metastatic breast cancers

It’s only fair to share… FDA approves new treatment for certain advanced or metastatic breast cancers The U.S. Food and Drug Administration today approved Verzenio (abemaciclib) to treat adult patients who have hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer that has progressed after taking therapy that alters …

Vaborbactam, Ваборбактам , فابورباكتام , 法硼巴坦 ,

It’s only fair to share…   Vaborbactam  RN: 1360457-46-0 UNII: 1C75676F8V Molecular Formula. C12-H16-B-N-O5-S Molecular Weight. 297.1374 1,2-Oxaborinane-6-acetic acid, 2-hydroxy-3-((2-(2-thienyl)acetyl)amino)-, (3R,6S)- B1([C@H](CC[C@H](O1)CC(=O)O)NC(=O)Cc2cccs2)O RPX7009 A beta-lactamase inhibitor. Treatment of Bacterial Infection {(3R,6S)-2-Hydroxy-3-[(2-thienylacetyl)amino]-1,2-oxaborinan-6-yl}acetic acid 2-[(3R,6S)-2-hydroxy-3-[(2-thiophen-2-ylacetyl)amino]oxaborinan-6-yl]acetic acid 1,2-Oxaborinane-6-acetic acid, 2-hydroxy-3-[[2-(2-thienyl)acetyl]amino]-, (3R,6S)- Ваборбактам [Russian] فابورباكتام [Arabic] 法硼巴坦 [Chinese] Originator Rempex Pharmaceuticals Developer The Medicines Company; US Department of Health and Human Services Class Antibacterials; Pyrrolidines; Small molecules; Thienamycins Mechanism …

FDA approval brings first gene therapy to the United States

It’s only fair to share… FDA approval brings first gene therapy to the United States 08/30/2017 The U.S. Food and Drug Administration issued a historic action today making the first gene therapy available in the United States, ushering in a new approach to the treatment of cancer and other serious and life-threatening diseases The U.S. …

FDA approves Mylotarg (gemtuzumab ozogamicin) for treatment of acute myeloid leukemia

It’s only fair to share… FDA approves Mylotarg for treatment of acute myeloid leukemia 09/01/2017 The U.S. Food and Drug Administration today approved Mylotarg (gemtuzumab ozogamicin) for the treatment of adults with newly diagnosed acute myeloid leukemia whose tumors express the CD33 antigen (CD33-positive AML). The FDA also approved Mylotarg for the treatment of patients …

FDA approves new antibacterial drug Vabomere (meropenem, vaborbactam)

It’s only fair to share… Meropenem Beta-lactamase inhibitor vaborbactam FDA approves new antibacterial drug 08/29/2017 The U.S. Food and Drug Administration today approved Vabomere for adults with complicated urinary tract infections (cUTI), including a type of kidney infection, pyelonephritis, caused by specific bacteria. Vabomere is a drug containing meropenem, an antibacterial, and vaborbactam, which inhibits …

Enasidenib, Энасидениб , إيناسيدينيب ,伊那尼布 ,

It’s only fair to share…   Enasidenib Molecular Formula C19H17F6N7O Average mass 473.375 2-Propanol, 2-methyl-1-[[4-[6-(trifluoromethyl)-2-pyridinyl]-6-[[2-(trifluoromethyl)-4-pyridinyl]amino]-1,3,5-triazin-2-yl]amino]- 2-Methyl-1-[[4-[6-(trifluoromethyl)-2-pyridinyl]-6-[[2-(trifluoromethyl)-4-pyridinyl]amino]-1,3,5-triazin-2-yl]amino]-2-propanol 2-Methyl-1-(4-(6-(trifluoromethyl)pyridin-2-yl)-6-(2-(trifluoromethyl)pyridin-4-ylamino)-1,3,5-triazin-2-ylamino)propan-2-ol   AG-221 CC-90007 1446502-11-9[RN] enasidenib Enasidenib énasidénib enasidenibum UNII:3T1SS4E7AG Энасидениб[Russian] إيناسيدينيب[Arabic] 伊那尼布[Chinese] 2-methyl-1-[(4-[6-(trifluoromethyl)pyridin-2-yl]-6-{[2-(trifluoromethyl)pyridin-4-yl]amino}-1,3,5-triazin-2-yl)amino]propan-2-ol 2-methyl-1-[[4-[6-(trifluoromethyl)pyridin-2-yl]-6-[[2-(trifluoromethyl)pyridin-4-yl]amino]-1,3,5-triazin-2-yl]amino]propan-2-ol 2-methyl-1-(4-(6-(trifluoromethyl)pyridin-2-yl)-6-(2-(trifluoromethyl)pyridin-4-ylamino)-1,3,5-triazin-2-ylamino)propan-2-ol Originator Agios Pharmaceuticals Developer Celgene Corporation Mechanism Of Action Isocitrate dehydrogenase 2 inhibitor Who Atc Codes L01 (Antineoplastic Agents) Ephmra Codes L1 (Antineoplastics) Indication Cancer …

FDA approves new targeted treatment Idhifa (enasidenib)for relapsed or refractory acute myeloid leukemia

It’s only fair to share… FDA approves new targeted treatment for relapsed or refractory acute myeloid leukemia 08/01/2017 The U.S. Food and Drug Administration today approved Idhifa (enasidenib) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a specific genetic mutation. The drug is approved for use with …