2019 FDA Approved Drugs

Cardiology/Vascular Diseases

Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis) ; FoldRx Pharmaceuticals; For the treatment of cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis, Approved May 2019

Dental and Oral Health

Myobloc (rimabotulinumtoxinB); US WorldMeds; For the treatment of chronic sialorrhea in adults, Approved August 2019

Otezla (apremilast); Celgene; For the treatment of adults with oral ulcers associated with Behçet’s Disease, Approved July 2019

Dermatology

Duobrii (halobetasol propionate and tazarotene) ; Ortho Dermatologics; For the treatment of plaque psoriasis , Approved April 2019

Jeuveau (prabotulinumtoxinA-xvfs); Evolus; For the improvement of glabellar lines, Approved February 2019

Skyrizi (risankizumab-rzaa) ; AbbVie; For the treatment of plaque psoriasis, Approved April 2019

Endocrinology

Jatenzo (testosterone undecanoate); Clarus Therapeutics; For the treatment of male conditions associated with a deficiency or absence of endogenous testosterone , Approved March 2019

Family Medicine

Tosymra (sumatriptan) nasal spray; Dr. Reddy’s Labs; For the treatment of acute migraine in adults, Approved January 2019

Gastroenterology

Keytruda (pembrolizumab) ; Merck; For the treatment of recurrent esophageal cancer with PD-L1 expressing tumors , Approved July 2019

Recarbrio (imipenem, cilastatin, and relebactam); Merck; For the treatment of complicated intra-abdominal and urinary tract infections, Approved July 2019

Genetic Disease

Esperoct [antihemophilic factor (recombinant), glycopegylated-exei]; Novo Nordisk; For the treatment of hemophilia A, Approved February 2019

Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis) ; FoldRx Pharmaceuticals; For the treatment of cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis, Approved May 2019

Zolgensma (onasemnogene abeparvovec-xioi) ; Avexis; For the treatment of pediatrics <2 years of age with spinal muscular atrophy with bi-allelic mutations in the SMN1 gene, Approved May 2019

Hematology

Cablivi (caplacizumab-yhdp); Ablynx; For the treatment of acquired thrombotic thrombocytopenic purpura, Approved February 2019

Esperoct [antihemophilic factor (recombinant), glycopegylated-exei]; Novo Nordisk; For the treatment of hemophilia A, Approved February 2019

Inrebic (fedratinib); Celgene; For the treatment of myelofibrosis, Approved August 2019

Polivy (polatuzumab vedotin-piiq) ; Genentech; For the treatment of diffuse large B-cell lymphoma, Approved June 2019

Venclexta (venetoclax) plus Gazyva (obinutuzumab); Genentech and AbbVie; For the treatment of chronic lymphocytic leukemia or small lymphocytic lymphoma , Approved May 2019

Xpovio (selinexor) ; Karyopharm Therapeutics; For the treatment of adults with relapsed or refractory multiple myeloma , Approved July 2019

Hepatology (Liver, Pancreatic, Gall Bladder)

Cyramza (ramucirumab) ; Eli Lilly; For the treatment of hepatocellular carcinoma with elevated alpha-fetoprotein (AFP), Approved May 2019

Egaten (triclabendazole); Novartis; For the treatment of fascioliasis (liver fluke infestation), Approved February 2019

Immunology

Asceniv (Immune Globulin Intravenous, Human – slra 10% Liquid); ADMA Biologics; For the treatment of Primary Humoral Immunodeficiency Disease , Approved April 2019

Dovato (dolutegravir and lamivudine) ; ViiV Healthcare; For the treatment of HIV-1 infection in adults, Approved April 2019

Otezla (apremilast); Celgene; For the treatment of adults with oral ulcers associated with Behçet’s Disease, Approved July 2019

Ruzurgi (amifampridine); Jacobus Pharmaceuticals; For the treatment of Lambert-Eaton myasthenic syndrome in pediatrics, Approved May 2019

Infections and Infectious Diseases

Dengvaxia (Dengue Tetravalent Vaccine, Live) ; sanofi pasteur; For the prevention of dengue disease, Approved May 2019

Dovato (dolutegravir and lamivudine) ; ViiV Healthcare; For the treatment of HIV-1 infection in adults, Approved April 2019

Egaten (triclabendazole); Novartis; For the treatment of fascioliasis (liver fluke infestation), Approved February 2019

Jakafi (ruxolitinib); Incyte; For the treatment of steroid-refractory acute graft-versus-host disease in adults and pediatrics >12 years , Approved May 2019

Pretomanid tablets; TB Alliance; For the treatment of adults with drug resistant tuberculosis, Approved August 2019

Recarbrio (imipenem, cilastatin, and relebactam); Merck; For the treatment of complicated intra-abdominal and urinary tract infections, Approved July 2019

Xenleta (lefamulin) ; Nabriva Therapeutics; For the treatment of community acquired bacterial pneumonia, Approved August 2019

Musculoskeletal

Cimzia (certolizumab pegol); UCB; For the treatment of non-radiographic axial spondyloarthritis, Approved March 2019

Evenity (romosozumab-aqqg); Amgen; For the treatment of osteoporosis in postmenopausal women at high risk for fracture, Approved April 2019

Mavenclad (cladribine) ; Merck; For the treatment of relapsing multiple sclerosis, Approved March 2019

Mayzent (siponimod); Novartis; For the treatment of relapsing multiple sclerosis, Approved March 2019

Rinvoq (upadacitinib); AbbVie; For the treatment of rheumatoid arthritis, Approved August 2019

Ruzurgi (amifampridine); Jacobus Pharmaceuticals; For the treatment of Lambert-Eaton myasthenic syndrome in pediatrics, Approved May 2019

Taltz (ixekizumab); Eli Lilly; For the treatment of active ankylosing spondylitis, Approved August 2019

Zolgensma (onasemnogene abeparvovec-xioi) ; Avexis; For the treatment of pediatrics <2 years of age with spinal muscular atrophy with bi-allelic mutations in the SMN1 gene, Approved May 2019

Nephrology

Bavencio (avelumab) plus Inlyta (axitinib) ; Merck and Pfizer; For the first line treatment of advanced renal cell carcinoma, Approved May 2019

Keytruda (pembrolizumab); Merck; For the treatment of advanced renal cell carcinoma, Approved April 2019

Neurology

Wakix (pitolisant) ; Bioprojet Pharma; For the treatment of excessive daytime sleepiness in adults with narcolepsy , Approved August 2019

Mavenclad (cladribine) ; Merck; For the treatment of relapsing multiple sclerosis, Approved March 2019

Mayzent (siponimod); Novartis; For the treatment of relapsing multiple sclerosis, Approved March 2019

Myobloc (rimabotulinumtoxinB); US WorldMeds; For the treatment of chronic sialorrhea in adults, Approved August 2019

Nayzilam (midazolam); UCB; For the treatment of intermittent, stereotypic episodes of frequent seizure activity, Approved May 2019

Nourianz (istradefylline); Kyowa-Kirin; For the adjuvant treatment of patients with Parkinson’s disease experiencing “off” episodes, Approved August 2019

Ruzurgi (amifampridine); Jacobus Pharmaceuticals; For the treatment of Lambert-Eaton myasthenic syndrome in pediatrics, Approved May 2019

Spravato (esketamine) nasal spray; Janssen Pharmaceuticals; For the treatment of treatment-resistant depression in adults, Approved March 2019

Sunosi (solriamfetol) ; Jazz Pharmaceuticals; For the treatment of excessive daytime sleepiness due to narcolepsy or obstructive sleep apnea, Approved March 2019

Tosymra (sumatriptan) nasal spray; Dr. Reddy’s Labs; For the treatment of acute migraine in adults, Approved January 2019

Obstetrics/Gynecology (Women’s Health)

Evenity (romosozumab-aqqg); Amgen; For the treatment of osteoporosis in postmenopausal women at high risk for fracture, Approved April 2019

Herceptin Hylecta (trastuzumab and hyaluronidase-oysk); Halozyme; For the treatment of HER2-overexpressing breast cancer, Approved February 2019

Piqray (alpelisib) ; Novartis; For the treatment of HR+, HER2-negative, PIK3CA-mutated advanced or metastatic breast cancer, Approved May 2019

Tecentriq (atezolizumab); Genentech/Roche; For the treatment of triple negative breast cancer, Approved March 2019

Vyleesi (bremelanotide injection); AMAG Pharmaceuticals; For the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder, Approved June 2019

Zulresso (brexanolone); Sage Therapeutics; For the treatment of postpartum depression, Approved March 2019

Oncology

Balversa (erdafitinib); Janssen Oncology; For the treatment of locally advanced or metastatic urothelial carcinoma , Approved April 2019

Bavencio (avelumab) plus Inlyta (axitinib) ; Merck and Pfizer; For the first line treatment of advanced renal cell carcinoma, Approved May 2019

Cyramza (ramucirumab) ; Eli Lilly; For the treatment of hepatocellular carcinoma with elevated alpha-fetoprotein (AFP), Approved May 2019

Herceptin Hylecta (trastuzumab and hyaluronidase-oysk); Halozyme; For the treatment of HER2-overexpressing breast cancer, Approved February 2019

Inrebic (fedratinib); Celgene; For the treatment of myelofibrosis, Approved August 2019

Keytruda (pembrolizumab) ; Merck; For the treatment of recurrent esophageal cancer with PD-L1 expressing tumors , Approved July 2019

Keytruda (pembrolizumab); Merck; previously treated metastatic small cell lung cancer, Approved June 2019

Keytruda (pembrolizumab); Merck; For the treatment of advanced renal cell carcinoma, Approved April 2019

Keytruda (pembrolizumab); Merck; For the treatment of stage III non-small cell lung cancer, Approved April 2019

Nubeqa (darolutamide); Bayer; For the treatment of non-metastatic castration-resistant prostate cancer, Approved July 2019

Piqray (alpelisib) ; Novartis; For the treatment of HR+, HER2-negative, PIK3CA-mutated advanced or metastatic breast cancer, Approved May 2019

Polivy (polatuzumab vedotin-piiq) ; Genentech; For the treatment of diffuse large B-cell lymphoma, Approved June 2019

Rozlytrek (entrectinib); Genentech; For the treatment of ROS1-positive non-small cell lung cancer and NTRK Gene Fusion-Positive Solid Tumors, Approved August 2019

Tecentriq (atezolizumab); Genentech/Roche; For the treatment of extensive-stage small cell lung cancer , Approved March 2019

Tecentriq (atezolizumab); Genentech/Roche; For the treatment of triple negative breast cancer, Approved March 2019

Turalio (pexidartinib); Daiichi Sankyo; For the treatment of symptomatic tenosynovial giant cell tumor, Approved August 2019

Venclexta (venetoclax) plus Gazyva (obinutuzumab); Genentech and AbbVie; For the treatment of chronic lymphocytic leukemia or small lymphocytic lymphoma , Approved May 2019

Xpovio (selinexor) ; Karyopharm Therapeutics; For the treatment of adults with relapsed or refractory multiple myeloma , Approved July 2019

Ophthalmology

Rocklatan (netarsudil and latanoprost ophthalmic solution); Aerie Pharmaceuticals; For the treatment of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension, Approved March 2019

Orthopedics/Orthopedic Surgery

Taltz (ixekizumab); Eli Lilly; For the treatment of active ankylosing spondylitis, Approved August 2019

Otolaryngology (Ear, Nose, Throat)

Dupixent (dupilumab); Regeneron Pharmaceuticals and Sanofi; For the treatment of chronic rhinosinusitis with nasal polyposis in adults , Approved June 2019

Keytruda (pembrolizumab) ; Merck; For the treatment of recurrent esophageal cancer with PD-L1 expressing tumors , Approved July 2019

Pediatrics/Neonatology

Nayzilam (midazolam); UCB; For the treatment of intermittent, stereotypic episodes of frequent seizure activity, Approved May 2019

Ruzurgi (amifampridine); Jacobus Pharmaceuticals; For the treatment of Lambert-Eaton myasthenic syndrome in pediatrics, Approved May 2019

Zolgensma (onasemnogene abeparvovec-xioi) ; Avexis; For the treatment of pediatrics <2 years of age with spinal muscular atrophy with bi-allelic mutations in the SMN1 gene, Approved May 2019

Psychiatry/Psychology

Spravato (esketamine) nasal spray; Janssen Pharmaceuticals; For the treatment of treatment-resistant depression in adults, Approved March 2019

Zulresso (brexanolone); Sage Therapeutics; For the treatment of postpartum depression, Approved March 2019

Pulmonary/Respiratory Diseases

Duaklir Pressair (aclidinium bromide and formoterol fumarate) ; Circassia Pharmaceuticals; For the maintenance treatment of chronic obstructive pulmonary disease, Approved April 2019

Keytruda (pembrolizumab); Merck; For the treatment of stage III non-small cell lung cancer, Approved April 2019

Keytruda (pembrolizumab); Merck; previously treated metastatic small cell lung cancer, Approved June 2019

Pretomanid tablets; TB Alliance; For the treatment of adults with drug resistant tuberculosis, Approved August 2019

Rozlytrek (entrectinib); Genentech; For the treatment of ROS1-positive non-small cell lung cancer and NTRK Gene Fusion-Positive Solid Tumors, Approved August 2019

Sunosi (solriamfetol) ; Jazz Pharmaceuticals; For the treatment of excessive daytime sleepiness due to narcolepsy or obstructive sleep apnea, Approved March 2019

Tecentriq (atezolizumab); Genentech/Roche; For the treatment of extensive-stage small cell lung cancer , Approved March 2019

Xenleta (lefamulin) ; Nabriva Therapeutics; For the treatment of community acquired bacterial pneumonia, Approved August 2019

Rare Diseases and Disorders

Otezla (apremilast); Celgene; For the treatment of adults with oral ulcers associated with Behçet’s Disease, Approved July 2019

Rheumatology

Cimzia (certolizumab pegol); UCB; For the treatment of non-radiographic axial spondyloarthritis, Approved March 2019

Rinvoq (upadacitinib); AbbVie; For the treatment of rheumatoid arthritis, Approved August 2019

Urology

Balversa (erdafitinib); Janssen Oncology; For the treatment of locally advanced or metastatic urothelial carcinoma , Approved April 2019

Jatenzo (testosterone undecanoate); Clarus Therapeutics; For the treatment of male conditions associated with a deficiency or absence of endogenous testosterone , Approved March 2019

Nubeqa (darolutamide); Bayer; For the treatment of non-metastatic castration-resistant prostate cancer, Approved July 2019

Recarbrio (imipenem, cilastatin, and relebactam); Merck; For the treatment of complicated intra-abdominal and urinary tract infections, Approved July 2019

Vaccines

Dengvaxia (Dengue Tetravalent Vaccine, Live) ; sanofi pasteur; For the prevention of dengue disease, Approved May 2019