New Drugs of ,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/ Approved Indication

Transcription

1 1 New Drugs of ,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/ Approved Indication Company Aliqopa Copanlisib Dihydrochloride Intravenous Bayer HealthCare Pharmaceuticals Inc. Alunbrig Brigatinib Tablets ARIAD Pharmaceuticals, Inc. Austedo Deutetrabenazine Tablets Teva Pharmaceuticals USA, Inc. Bavencio Avelumab Intravenous EMD Serono, Inc. Baxdela Delafloxacin Meglumine Tablets and Intravenous Melinta Therapeutics, Inc. Treatment of adult patients with relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies Treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib Treatment of chorea associated with Huntington s disease Treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC) and locally advanced or metastatic urothelial carcinoma (UC) who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinumcontaining chemotherapy Treatment of acute bacterial skin and skin structure infections caused by susceptible isolates of gram-positive and negative organisms Benznidazole Benznidazole Tablets Exeltis USA, Inc Besponsa Inotuzumab Ozogamicin Intravenous Wyeth Pharmaceuticals, Inc Brineura Cerliponase Alfa Intraventricular BioMarin Pharmaceutical Inc Bevyxxa Betrixaban Capsules Portola Pharmaceuticals, Inc. Calquence Acalabrutinib Capsules Treatment of Chagas disease (American trypanosomiasis), caused by Trypanosoma cruzi, in pediatric patients 2 to 12 years of age Treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) Indicated to slow the loss of ambulation in symptomatic pediatric patients 3 years of age and older with late infantile neuronal ceroid lipofuscinosis type 2 (CLN2), also known as tripeptidyl peptidase 1 (TPP1) deficiency Prophylaxis of venous thromboembolism in adult patients hospitalized for an acute medical illness who are at risk for thromboembolic complications due to moderate or severe restricted mobility and other risk factors for VTE. Treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy

2 2 AstraZeneca Pharmaceuticals LP Cyltezo Adalimumab-adbm Subcutaneous Boehringer Ingelheim Pharmaceuticals, Inc. Dupixent Dupilumab Subcutaneous Regeneron Pharmaceuticals, Inc. Emflaza Deflazacort Tablets and Oral Suspension Marathon Pharmaceuticals, LLC Fasenra Benralizumab Subcutaneous AstraZeneca Pharmaceuticals LP Giapreza Angiotensin II Intravenous Infusion La Jolla Pharmaceutical Company Haegarda C1 Esterase Inhibitor [Human] Subcutaneous CSL Behring LLC Hemlibra Emicizumab-kxwh Subcutaneous Genentech, Inc Heplisav-B Hepatitis B Vaccine (Recombinant), Adjuvanted Solution for Intramuscular Dynavax Technologies Idhifa Enasidenib Mesylate Tablets Celgene Treatment of Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Adult Crohn s Disease, Ulcerative Colitis, and Plaque Psoriasis Treatment of adult patients with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Treatment of Duchenne muscular dystrophy in patients 5 years of age and older Add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype Vasoconstrictor to increase blood pressure in adults with septic or other distributive shock Routine prophylaxis to prevent Hereditary Angioedema (HAE) attacks in adolescent and adult patients Routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A (congenital factor VIII deficiency) with factor VIII inhibitors Prevention of infection caused by all known subtypes of hepatitis B virus in adults 18 years of age and older. Treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDAapproved test

3 3 Imfinzi Durvalumab Intravenous AstraZeneca Pharmaceuticals LP Ingrezza Valbenazine Tosylate Capsules Neurocrine Biosciences, Inc. Ixifi Infliximab-qbtx Intravenous Pfizer, Inc. Kedrab Rabies Immune Globulin Intramuscular Kedrion Biopharma Inc. Kevzara Sarilumab Subcutaneous Sanofi-Aventis U.S. LLC Kisqali Ribociclib Succinate Tablets Novartis Pharmaceuticals Kymriah Tisagenlecleucel Novartis Pharmaceuticals Macrilen Macimorelin Oral Solution Aeterna Zentaris Mavyret Glecaprevir and Pibrentasvir Tablets AbbVie, Inc Mepsevii Vestronidase-Alfa-vjbk intravenous Ultragenyx Pharmaceutical Inc. Mvasi Bevacizumab-awwb Intravenous Solution Treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy Treatment of tardive dyskinesia. Treatment of Crohn s Disease, Pediatric Crohn s Disease, Ulcerative Colitis, Rheumatoid Arthritis in combination with methotrexate, Ankylosing Spondylitis, Psoriatic Arthritis, and Plaque Psoriasis Passive, transient post-exposure prophylaxis (PEP) of rabies infection, when given immediately after contact with a rabid or possibly rabid animal Treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs Indicated in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor (HR)- positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer Treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse Indicated for the diagnosis of adult growth hormone deficiency Treatment of patients with chronic HCV genotype 1, 2, 3, 4, 5 or 6 infection without cirrhosis and with compensated cirrhosis as well as patients with HCV genotype 1 infection, who previously have been treated with a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor, but not both. Treatment of Mucopolysaccharidosis VII (MPS VII, Sly syndrome) in pediatric and adult patients Metastatic colorectal cancer, Metastatic colorectal cancer, Non-squamous non-small cell lung cancer, Glioblastoma, Metastatic renal cell carcinoma, and Cervical cancer

4 4 Amgen Inc. Nerlynx Neratinib Maleate Tablets Puma Biotechnology, Inc. Ocrevus Ocrelizumab Intravenous Genentech, Inc. Odactra House Dust Mite Allergen Extract Sublingual Tablets. Ogivri Trastuzumab-dkst Intravenous Mylan Ozempic Semaglutide Subcutaneous Novo Nordisk Inc. Parsabiv Etelcalcetide Intravenous KAI Pharmaceuticals, Inc. Prevymis Letermovir Tablets and. Radicava Edaravone Intravenous MT Pharma America, Inc. Rebinyn Factor IX, GlycoPEGylated Intravenous Novo Nordisk Inc. Renflexis Infliximab-adba Intravenous Rhopressa Netarsudil ophthalmic solution Aerie Pharmaceuticals, Inc Indicated for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, to follow adjuvant trastuzumab-based therapy Treatment of patients with relapsing or primary progressive forms of multiple sclerosis Indicated as immunotherapy for house dust mite (HDM)- induced allergic rhinitis, with or without conjunctivitis in adults 18 through 65 years of age Treatment of HER2-overexpressing breast cancer and treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma in adults with type 2 diabetes mellitus Treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis. Prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT). Treatment of amyotrophic lateral sclerosis (ALS) Indicated for use in adults and children with hemophilia B for on-demand treatment and control of bleeding episodes or perioperative management of bleeding Treatment of Crohn s Disease, Pediatric Crohn s Disease, Ulcerative Colitis, Rheumatoid Arthritis in combination with methotrexate, Ankylosing Spondylitis, Psoriatic Arthritis, and Plaque Psoriasis Indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension

5 5 Rituxan Hycela Rituximab / Hyaluronidase Human Subcutaneous Genentech, Inc Rydapt Midostaurin Capsules Novartis Pharmaceuticals Segluromet Ertugliflozin / Metformin Hydrochloride Tablets Shingrix Zoster Vaccine Recombinant, Adjuvanted Intramuscular GlaxoSmithKline Siliq Brodalumab Subcutaneous Valeant Pharmaceuticals North America LLC Solosec Secnidazole Oral Granules Symbiomix Therapeutics LLC Steglatro Ertugliflozin Tablets Steglujan Ertugliflozin / Sitagliptin Tablets Symproic Naldemedine Tosylate Tablets Shionogi Inc. Tremfya Guselkumab Subcutaneous Janssen Biotech, Inc Trulance Plecanatide Tablets Synergy Pharmaceuticals Inc. Treatment of adult patients with Follicular Lymphoma (FL), Diffuse Large B-cell Lymphoma (DLBCL), and Chronic Lymphocytic Leukemia (CLL) Treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3 mutation positive as detected by an FDA-approved test, in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation in adults with type 2 diabetes mellitus who are not adequately controlled on a regimen containing ertugliflozin or metformin, or in patients who are already treated with both ertugliflozin and metformin. Prevention of herpes zoster (shingles) in adults aged 50 years and older. Treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies. Treatment of bacterial vaginosis in adult women. in adults with type 2 diabetes mellitus in adults with type 2 diabetes mellitus when treatment with both ertugliflozin and sitagliptin is appropriate. Treatment of opioid-induced constipation Treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Treatment of chronic idiopathic constipation

6 6 Tymlos Abaloparatide Subcutaneous Radius Health, Inc. Vabomere Meropenem and Vaborbactam Intravenous Verzenio Abemaciclib Tablets Lilly USA, LLC Vosevi Sofosbuvir, Velpatasvir, and Voxilaprevir tablets Gilead Sciences, Inc. Vyzulta Latanoprostene Bunod Ophthalmic Solution Bausch & Lomb Xadago Safinamide Mesylate Tablets US WorldMeds, LLC Xepi Ozenoxacin Cream Medimetriks Pharmaceuticals, Inc Xermelo Telotristat Etiprate Tablets Lexicon Pharmaceuticals, Inc. Yescarta Axicabtagene Ciloleucel Intravenous Kite Pharma, Inc Zejula Niraparib Tosylate Capsules Tesaro, Inc. Treatment of postmenopausal women with osteoporosis at high risk for fracture. Treatment of complicated urinary tract infections including pyelonephritis. In combination with fulvestrant for the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy and as monotherapy for the treatment of adult patients with HR positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting Treatment of adult patients with chronic HCV infection without cirrhosis or with compensated cirrhosis (Child- Pugh A) who have genotype 1, 2, 3, 4, 5, or 6 infection and have previously been treated with an HCV regimen containing an NS5A inhibitor or genotype 1a or 3 infection and have previously been treated with an HCV regimen containing sofosbuvir without an NS5A inhibitor. Reduction of intraocular pressure in patients with openangle glaucoma or ocular hypertension Adjunctive treatment to levodopa/carbidopa in patients with Parkinson s disease experiencing off episodes Topical treatment of impetigo due to Staphylococcus aureus or Streptococcus pyogenes in adult and pediatric patients 2 months of age and older Treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy Treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma Maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy