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.
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Find out more about the types of drugs included in this listing.
Dermatology
Jeuveau (prabotulinumtoxinA-xvfs); Evolus;
For the improvement of glabellar lines, Approved February 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
Genetic Disease
Esperoct [antihemophilic factor (recombinant), glycopegylated-exei]; Novo Nordisk;
For the treatment of hemophilia A, Approved February 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
Hepatology (Liver, Pancreatic, Gall Bladder)
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
Infections and Infectious Diseases
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
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
Neurology
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
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
Tecentriq (atezolizumab); Genentech/Roche;
For the treatment of triple negative breast cancer, Approved March 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
Herceptin Hylecta (trastuzumab and hyaluronidase-oysk); Halozyme;
For the treatment of HER2-overexpressing breast cancer, Approved February 2019
Keytruda (pembrolizumab); Merck;
For the treatment of stage III non-small cell lung cancer, Approved April 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
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
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
Keytruda (pembrolizumab); Merck;
For the treatment of stage III non-small cell lung cancer, Approved April 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
Rheumatology
Cimzia (certolizumab pegol); UCB;
For the treatment of non-radiographic axial spondyloarthritis, Approved March 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
The criteria for CenterWatch's FDA-Approved Drugs follow the definitions established by the Tufts Center for the Study of Drug Development and the FDA's definitions of a new drug approval or a new molecular entity.
Database inclusions:
New Molecular Entities (NME) is defined by the FDA as a medication containing an active substance that has never before been approved for marketing in any form in the United States. The database also includes some recombinant proteins and biologics that were approved by the FDA's Center for Drug Evaluation and Research (CDER).
Database exclusions:
Diagnostic agents, generics, over-the-counter products, medical devices, and biologic compounds not approved by CDER. Other exclusions are new dosages and new administrations of previously-approved compounds.
