Category «FDA 2017»

FDA approves first subcutaneous C1 Esterase Inhibitor to treat rare genetic disease

It’s only fair to share… FDA approves first subcutaneous C1 Esterase Inhibitor to treat rare genetic disease 06/22/2017   The U.S. Food and Drug Administration today approved Haegarda, the first C1 Esterase Inhibitor (Human) for subcutaneous (under the skin) administration to prevent Hereditary Angioedema (HAE) attacks in adolescent and adult patients. The subcutaneous route of …

FDA approves first generic Strattera (atomoxetine) for the treatment of ADHD

It’s only fair to share… FDA approves first generic Strattera (atomoxetine) for the treatment of ADHD 05/30/2017 04:49 PM EDT The U.S. Food and Drug Administration today approved the first generic versions of Strattera (atomoxetine) to treat attention-deficit/hyperactivity disorder (ADHD) in pediatric and adult patients. 05/30/2017 The U.S. Food and Drug Administration today approved the …

FDA approves first drug Actemra (tocilizumab) to specifically treat giant cell arteritis

It’s only fair to share… FDA approves first drug to specifically treat giant cell arteritis 05/22/2017 The U.S. Food and Drug Administration today expanded the approved use of subcutaneous Actemra (tocilizumab) to treat adults with giant cell arteritis. This new indication provides the first FDA-approved therapy, specific to this type of vasculitis. May 22, 2017 …

FDA approves drug to treat ALS, Radicava (Edaravone) , эдаравон, إيدارافون , 依达拉奉 ,ラジカット,

It’s only fair to share… FDA approves drug to treat ALS 05/05/2017 The U.S. Food and Drug Administration today approved Radicava (edaravone) to treat patients with amyotrophic lateral sclerosis (ALS), commonly referred to as Lou Gehrig’s disease. May 5, 2017 Release The U.S. Food and Drug Administration today approved Radicava (edaravone) to treat patients with …

FDA approves new combination treatment for acute myeloid leukemia, Rydapt (midostaurin)

It’s only fair to share… MIDOSTAURIN FDA approves new combination treatment for acute myeloid leukemia 04/28/2017 The U.S. Food and Drug Administration today approved Rydapt (midostaurin) for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who have a specific genetic mutation called FLT3, in combination with chemotherapy. The drug is approved …

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 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 …