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