New Drugs of New Drugs of 2017with table... · AstraZeneca Pharmaceuticals LP Add-on maintenance treatment…

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<p>1 </p> <p> 2 Clarke Drive, Suite 100 Cranbury, NJ 08512 1-800-597-6372 </p> <p>www.pharmacytimes.org </p> <p>New Drugs of 20171,3,5,7,10,14,16,20,22,24,26,28,30,32,34,36,38,40,41,43,45-86 Brand Name/ Generic Name/ </p> <p>Company </p> <p>Approved Indication </p> <p>Aliqopa </p> <p>Copanlisib Dihydrochloride </p> <p>Intravenous Injection </p> <p>Bayer HealthCare </p> <p>Pharmaceuticals Inc. </p> <p>Treatment of adult patients with relapsed follicular lymphoma </p> <p>(FL) who have received at least two prior systemic therapies </p> <p>Alunbrig </p> <p>Brigatinib Tablets </p> <p>ARIAD Pharmaceuticals, Inc. </p> <p>Treatment of patients with anaplastic lymphoma kinase </p> <p>(ALK)-positive metastatic non-small cell lung cancer </p> <p>(NSCLC) who have progressed on or are intolerant to </p> <p>crizotinib </p> <p>Austedo </p> <p>Deutetrabenazine Tablets </p> <p>Teva Pharmaceuticals USA, Inc. </p> <p>Treatment of chorea associated with Huntingtons disease </p> <p>Bavencio </p> <p>Avelumab Intravenous </p> <p>Injection </p> <p>EMD Serono, Inc. </p> <p>Treatment of adults and pediatric patients 12 years and older </p> <p>with metastatic Merkel cell carcinoma (MCC) and locally </p> <p>advanced or metastatic urothelial carcinoma (UC) who have </p> <p>disease progression during or following platinum-containing </p> <p>chemotherapy or have disease progression within 12 months </p> <p>of neoadjuvant or adjuvant treatment with platinum-</p> <p>containing chemotherapy </p> <p>Baxdela </p> <p>Delafloxacin Meglumine </p> <p>Tablets and Intravenous </p> <p>Injection </p> <p>Melinta Therapeutics, Inc. </p> <p>Treatment of acute bacterial skin and skin structure infections </p> <p>caused by susceptible isolates of gram-positive and negative </p> <p>organisms </p> <p>Benznidazole </p> <p>Benznidazole Tablets </p> <p>Exeltis USA, Inc </p> <p>Treatment of Chagas disease (American trypanosomiasis), </p> <p>caused by Trypanosoma cruzi, in pediatric patients 2 to 12 </p> <p>years of age </p> <p>Besponsa </p> <p>Inotuzumab Ozogamicin </p> <p>Intravenous Injection </p> <p>Wyeth Pharmaceuticals, Inc </p> <p>Treatment of adults with relapsed or refractory B-cell </p> <p>precursor acute lymphoblastic leukemia (ALL) </p> <p>Brineura </p> <p>Cerliponase Alfa </p> <p>Intraventricular Injection </p> <p>BioMarin Pharmaceutical Inc </p> <p>Indicated to slow the loss of ambulation in symptomatic </p> <p>pediatric patients 3 years of age and older with late </p> <p>infantile neuronal ceroid lipofuscinosis type 2 (CLN2), </p> <p>also known as tripeptidyl peptidase 1 (TPP1) deficiency </p> <p>Bevyxxa </p> <p>Betrixaban Capsules </p> <p>Portola Pharmaceuticals, Inc. </p> <p>Prophylaxis of venous thromboembolism in adult patients </p> <p>hospitalized for an acute medical illness who are at risk for </p> <p>thromboembolic complications due to moderate or severe </p> <p>restricted mobility and other risk factors for VTE. </p> <p>Calquence </p> <p>Acalabrutinib Capsules </p> <p>Treatment of adult patients with mantle cell lymphoma </p> <p>(MCL) who have received at least one prior therapy </p> <p>http://www.pharmacytimes.org/</p> <p>2 </p> <p> 2 Clarke Drive, Suite 100 Cranbury, NJ 08512 1-800-597-6372 </p> <p>www.pharmacytimes.org </p> <p>AstraZeneca Pharmaceuticals LP </p> <p>Cyltezo </p> <p>Adalimumab-adbm </p> <p>Subcutaneous Injection </p> <p>Boehringer Ingelheim </p> <p>Pharmaceuticals, Inc. </p> <p>Treatment of Rheumatoid Arthritis, Juvenile Idiopathic </p> <p>Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Adult </p> <p>Crohns Disease, Ulcerative Colitis, and Plaque Psoriasis </p> <p>Dupixent </p> <p>Dupilumab Subcutaneous </p> <p>Injection </p> <p>Regeneron Pharmaceuticals, Inc. </p> <p>Treatment of adult patients with moderate-to-severe atopic </p> <p>dermatitis whose disease is not adequately controlled with </p> <p>topical prescription therapies or when those therapies are </p> <p>not advisable. </p> <p>Emflaza </p> <p>Deflazacort Tablets and Oral </p> <p>Suspension </p> <p>Marathon Pharmaceuticals, LLC </p> <p>Treatment of Duchenne muscular dystrophy in patients 5 </p> <p>years of age and older </p> <p>Fasenra </p> <p>Benralizumab Subcutaneous </p> <p>Injection </p> <p>AstraZeneca Pharmaceuticals LP </p> <p>Add-on maintenance treatment of patients with severe </p> <p>asthma aged 12 years and older, and with an eosinophilic </p> <p>phenotype </p> <p>Giapreza </p> <p>Angiotensin II Intravenous </p> <p>Infusion </p> <p>La Jolla Pharmaceutical </p> <p>Company </p> <p>Vasoconstrictor to increase blood pressure in adults with </p> <p>septic or other distributive shock </p> <p>Haegarda </p> <p>C1 Esterase Inhibitor </p> <p>[Human] Subcutaneous </p> <p>Injection </p> <p>CSL Behring LLC </p> <p>Routine prophylaxis to prevent Hereditary Angioedema </p> <p>(HAE) attacks in adolescent and adult patients </p> <p>Hemlibra </p> <p>Emicizumab-kxwh </p> <p>Subcutaneous Injection </p> <p>Genentech, Inc </p> <p>Routine prophylaxis to prevent or reduce the frequency of </p> <p>bleeding episodes in adult and pediatric patients with </p> <p>hemophilia A (congenital factor VIII deficiency) with </p> <p>factor VIII inhibitors </p> <p>Heplisav-B </p> <p>Hepatitis B Vaccine </p> <p>(Recombinant), Adjuvanted </p> <p>Solution for Intramuscular </p> <p>Injection </p> <p>Dynavax Technologies </p> <p>Corporation </p> <p>Prevention of infection caused by all known subtypes of </p> <p>hepatitis B virus in adults 18 years of age and older. </p> <p>Idhifa </p> <p>Enasidenib Mesylate Tablets </p> <p>Celgene Corporation </p> <p>Treatment of adult patients with relapsed or refractory </p> <p>acute myeloid leukemia (AML) with an isocitrate </p> <p>dehydrogenase-2 (IDH2) mutation as detected by an FDA-</p> <p>approved test </p> <p>http://www.pharmacytimes.org/</p> <p>3 </p> <p> 2 Clarke Drive, Suite 100 Cranbury, NJ 08512 1-800-597-6372 </p> <p>www.pharmacytimes.org </p> <p>Imfinzi </p> <p>Durvalumab Intravenous </p> <p>Injection </p> <p>AstraZeneca Pharmaceuticals LP </p> <p>Treatment of patients with locally advanced or metastatic </p> <p>urothelial carcinoma who have disease progression during </p> <p>or following platinum-containing chemotherapy or have </p> <p>disease progression within 12 months of neoadjuvant or </p> <p>adjuvant treatment with platinum-containing chemotherapy </p> <p>Ingrezza </p> <p>Valbenazine Tosylate Capsules </p> <p>Neurocrine Biosciences, Inc. </p> <p>Treatment of tardive dyskinesia. </p> <p>Ixifi </p> <p>Infliximab-qbtx Intravenous </p> <p>Injection </p> <p>Pfizer, Inc. </p> <p>Treatment of Crohns Disease, Pediatric Crohns Disease, </p> <p>Ulcerative Colitis, Rheumatoid Arthritis in combination </p> <p>with methotrexate, Ankylosing Spondylitis, Psoriatic </p> <p>Arthritis, and Plaque Psoriasis </p> <p>Kedrab </p> <p>Rabies Immune Globulin </p> <p>Intramuscular Injection </p> <p>Kedrion Biopharma Inc. </p> <p>Passive, transient post-exposure prophylaxis (PEP) of </p> <p>rabies infection, when given immediately after contact with </p> <p>a rabid or possibly rabid animal </p> <p>Kevzara </p> <p>Sarilumab Subcutaneous </p> <p>Injection </p> <p>Sanofi-Aventis U.S. LLC </p> <p>Treatment of adult patients with moderately to severely </p> <p>active rheumatoid arthritis who have had an inadequate </p> <p>response or intolerance to one or more disease-modifying </p> <p>antirheumatic drugs </p> <p>Kisqali </p> <p>Ribociclib Succinate Tablets </p> <p>Novartis Pharmaceuticals </p> <p>Corporation </p> <p>Indicated in combination with an aromatase inhibitor as </p> <p>initial endocrine-based therapy for the treatment of </p> <p>postmenopausal women with hormone receptor (HR)-</p> <p>positive, human epidermal growth factor receptor 2 </p> <p>(HER2)-negative advanced or metastatic breast cancer </p> <p>Kymriah </p> <p>Tisagenlecleucel </p> <p>Novartis Pharmaceuticals </p> <p>Corporation </p> <p>Treatment of patients up to 25 years of age with B-cell </p> <p>precursor acute lymphoblastic leukemia (ALL) that is </p> <p>refractory or in second or later relapse </p> <p>Macrilen </p> <p>Macimorelin Oral Solution </p> <p>Aeterna Zentaris </p> <p>Indicated for the diagnosis of adult growth hormone </p> <p>deficiency </p> <p>Mavyret </p> <p>Glecaprevir and Pibrentasvir </p> <p>Tablets </p> <p>AbbVie, Inc </p> <p>Treatment of patients with chronic HCV genotype 1, 2, 3, </p> <p>4, 5 or 6 infection without cirrhosis and with compensated </p> <p>cirrhosis as well as patients with HCV genotype 1 </p> <p>infection, who previously have been treated with a regimen </p> <p>containing an HCV NS5A inhibitor or an NS3/4A protease </p> <p>inhibitor, but not both. </p> <p>Mepsevii </p> <p>Vestronidase-Alfa-vjbk </p> <p>intravenous Injection </p> <p>Ultragenyx Pharmaceutical Inc. </p> <p>Treatment of Mucopolysaccharidosis VII (MPS VII, Sly </p> <p>syndrome) in pediatric and adult patients </p> <p>Mvasi </p> <p>Bevacizumab-awwb </p> <p>Intravenous Solution </p> <p>Metastatic colorectal cancer, Metastatic colorectal cancer, </p> <p>Non-squamous non-small cell lung cancer, Glioblastoma, </p> <p>Metastatic renal cell carcinoma, and Cervical cancer </p> <p>http://www.pharmacytimes.org/</p> <p>4 </p> <p> 2 Clarke Drive, Suite 100 Cranbury, NJ 08512 1-800-597-6372 </p> <p>www.pharmacytimes.org </p> <p>Amgen Inc. </p> <p>Nerlynx </p> <p>Neratinib Maleate Tablets </p> <p>Puma Biotechnology, Inc. </p> <p>Indicated for the extended adjuvant treatment of adult </p> <p>patients with early stage HER2-overexpressed/amplified </p> <p>breast cancer, to follow adjuvant trastuzumab-based </p> <p>therapy </p> <p>Ocrevus </p> <p>Ocrelizumab Intravenous </p> <p>Injection </p> <p>Genentech, Inc. </p> <p>Treatment of patients with relapsing or primary </p> <p>progressive forms of multiple sclerosis </p> <p>Odactra </p> <p>House Dust Mite Allergen </p> <p>Extract Sublingual Tablets </p> <p>Merck &amp; Co., Inc. </p> <p>Indicated as immunotherapy for house dust mite (HDM)-</p> <p>induced allergic rhinitis, with or without conjunctivitis in </p> <p>adults 18 through 65 years of age </p> <p>Ogivri </p> <p>Trastuzumab-dkst </p> <p>Intravenous Injection </p> <p>Mylan </p> <p>Treatment of HER2-overexpressing breast cancer and </p> <p>treatment of HER2-overexpressing metastatic gastric or </p> <p>gastroesophageal junction adenocarcinoma </p> <p>Ozempic </p> <p>Semaglutide Subcutaneous </p> <p>Injection </p> <p>Novo Nordisk Inc. </p> <p>Adjunct to diet and exercise to improve glycemic control </p> <p>in adults with type 2 diabetes mellitus </p> <p>Parsabiv </p> <p>Etelcalcetide Intravenous </p> <p>Injection </p> <p>KAI Pharmaceuticals, Inc. </p> <p>Treatment of secondary hyperparathyroidism (HPT) in </p> <p>adult patients with chronic kidney disease (CKD) on </p> <p>hemodialysis. </p> <p>Prevymis </p> <p>Letermovir Tablets and </p> <p>Injection </p> <p>Merck &amp; Co., Inc. </p> <p>Prophylaxis of cytomegalovirus (CMV) infection and </p> <p>disease in adult CMV-seropositive recipients [R+] of an </p> <p>allogeneic hematopoietic stem cell transplant (HSCT). </p> <p>Radicava </p> <p>Edaravone Intravenous </p> <p>Injection </p> <p>MT Pharma America, Inc. </p> <p>Treatment of amyotrophic lateral sclerosis (ALS) </p> <p>Rebinyn </p> <p>Factor IX, GlycoPEGylated </p> <p>Intravenous Injection </p> <p>Novo Nordisk Inc. </p> <p>Indicated for use in adults and children with hemophilia B </p> <p>for on-demand treatment and control of bleeding episodes </p> <p>or perioperative management of bleeding </p> <p>Renflexis </p> <p>Infliximab-adba Intravenous </p> <p>Injection </p> <p>Merck &amp; Co., Inc </p> <p>Treatment of Crohns Disease, Pediatric Crohns Disease, </p> <p>Ulcerative Colitis, Rheumatoid Arthritis in combination </p> <p>with methotrexate, Ankylosing Spondylitis, Psoriatic </p> <p>Arthritis, and Plaque Psoriasis </p> <p>Rhopressa </p> <p>Netarsudil ophthalmic solution </p> <p>Aerie Pharmaceuticals, Inc </p> <p>Indicated for the reduction of elevated intraocular pressure </p> <p>in patients with open-angle glaucoma or ocular </p> <p>hypertension </p> <p>http://www.pharmacytimes.org/</p> <p>5 </p> <p> 2 Clarke Drive, Suite 100 Cranbury, NJ 08512 1-800-597-6372 </p> <p>www.pharmacytimes.org </p> <p>Rituxan Hycela </p> <p>Rituximab / Hyaluronidase </p> <p>Human Subcutaneous </p> <p>Injection </p> <p>Genentech, Inc </p> <p>Treatment of adult patients with Follicular Lymphoma </p> <p>(FL), Diffuse Large B-cell Lymphoma (DLBCL), and </p> <p>Chronic Lymphocytic Leukemia (CLL) </p> <p>Rydapt </p> <p>Midostaurin Capsules </p> <p>Novartis Pharmaceuticals </p> <p>Corporation </p> <p>Treatment of adult patients with newly diagnosed acute </p> <p>myeloid leukemia (AML) that is FLT3 mutation positive as </p> <p>detected by an FDA-approved test, in combination with </p> <p>standard cytarabine and daunorubicin induction and </p> <p>cytarabine consolidation </p> <p>Segluromet </p> <p>Ertugliflozin / Metformin </p> <p>Hydrochloride Tablets </p> <p>Merck &amp; Co., Inc </p> <p>Adjunct to diet and exercise to improve glycemic control </p> <p>in adults with type 2 diabetes mellitus who are not </p> <p>adequately controlled on a regimen containing ertugliflozin </p> <p>or metformin, or in patients who are already treated with </p> <p>both ertugliflozin and metformin. </p> <p>Shingrix </p> <p>Zoster Vaccine Recombinant, </p> <p>Adjuvanted Intramuscular </p> <p>Injection </p> <p>GlaxoSmithKline </p> <p>Prevention of herpes zoster (shingles) in adults aged 50 </p> <p>years and older. </p> <p>Siliq </p> <p>Brodalumab Subcutaneous </p> <p>Injection </p> <p>Valeant Pharmaceuticals North </p> <p>America LLC </p> <p>Treatment of moderate to severe plaque psoriasis in adult </p> <p>patients who are candidates for systemic therapy or </p> <p>phototherapy and have failed to respond or have lost </p> <p>response to other systemic therapies. </p> <p>Solosec </p> <p>Secnidazole Oral Granules </p> <p>Symbiomix Therapeutics LLC </p> <p>Treatment of bacterial vaginosis in adult women. </p> <p>Steglatro </p> <p>Ertugliflozin Tablets </p> <p>Merck &amp; Co., Inc </p> <p>Adjunct to diet and exercise to improve glycemic control </p> <p>in adults with type 2 diabetes mellitus </p> <p>Steglujan </p> <p>Ertugliflozin / Sitagliptin </p> <p>Tablets </p> <p>Merck &amp; Co., Inc </p> <p>Adjunct to diet and exercise to improve glycemic control </p> <p>in adults with type 2 diabetes mellitus when treatment with </p> <p>both ertugliflozin and sitagliptin is appropriate. </p> <p>Symproic </p> <p>Naldemedine Tosylate Tablets </p> <p>Shionogi Inc. </p> <p>Treatment of opioid-induced constipation </p> <p>Tremfya </p> <p>Guselkumab Subcutaneous </p> <p>Injection </p> <p>Janssen Biotech, Inc </p> <p>Treatment of adult patients with moderate-to-severe plaque </p> <p>psoriasis who are candidates for systemic therapy or </p> <p>phototherapy. </p> <p>Trulance </p> <p>Plecanatide Tablets </p> <p>Synergy Pharmaceuticals Inc. </p> <p>Treatment of chronic idiopathic constipation </p> <p>http://www.pharmacytimes.org/</p> <p>6 </p> <p> 2 Clarke Drive, Suite 100 Cranbury, NJ 08512 1-800-597-6372 </p> <p>www.pharmacytimes.org </p> <p>Tymlos </p> <p>Abaloparatide Subcutaneous </p> <p>Injection </p> <p>Radius Health, Inc. </p> <p>Treatment of postmenopausal women with osteoporosis at </p> <p>high risk for fracture. </p> <p>Vabomere </p> <p>Meropenem and Vaborbactam </p> <p>Intravenous Injection </p> <p>Treatment of complicated urinary tract infections including </p> <p>pyelonephritis. </p> <p>Verzenio </p> <p>Abemaciclib Tablets </p> <p>Lilly USA, LLC </p> <p>In combination with fulvestrant for the treatment of women </p> <p>with hormone receptor (HR)-positive, human epidermal </p> <p>growth factor receptor 2 (HER2)-negative advanced or </p> <p>metastatic breast cancer with disease progression following </p> <p>endocrine therapy and as monotherapy for the treatment of </p> <p>adult patients with HR positive, HER2-negative advanced </p> <p>or metastatic breast cancer with disease progression </p> <p>following endocrine therapy and prior chemotherapy in the </p> <p>metastatic setting </p> <p>Vosevi </p> <p>Sofosbuvir, Velpatasvir, and </p> <p>Voxilaprevir tablets </p> <p>Gilead Sciences, Inc. </p> <p>Treatment of adult patients with chronic HCV infection </p> <p>without cirrhosis or with compensated cirrhosis (Child-</p> <p>Pugh A) who have genotype 1, 2, 3, 4, 5, or 6 infection and </p> <p>have previously been treated with an HCV regimen </p> <p>containing an NS5A inhibitor or genotype 1a or 3 infection </p> <p>and have previously been treated with an HCV regimen </p> <p>containing sofosbuvir without an NS5A inhibitor. </p> <p>Vyzulta Latanoprosten...</p>

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