2019 FDA Approved Drugs

The following database contains a listing of drugs approved by the Food and Drug Administration (FDA) for sale in the United States. Drug information typically includes the drug name, approval status, indication of use, and clinical trial results. Review descriptions for our medical therapeutic area list to help assist in your search.

Join our Drug Research Updates group on LinkedIn! 

Find out more about the types of drugs included in this listing.

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

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

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

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

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

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