2018 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
Ilumya (tildrakizumab-asmn); Sun Pharmaceuticals;
For the treatment of plaque psoriasis , Approved March 2018
Family Medicine
Aimovig (erenumab-aooe) ; Amgen;
For the preventive treatment of migraine in adults , Approved May 2018
Gastroenterology
Lutathera (lutetium Lu 177 dotatate); Advanced Accelerator Applications;
For the treatment of gastroenteropancreatic neuroendocrine tumors, Approved January 2018
Genetic Disease
Crysvita (burosumab-twza) ; Ultragenyx;
For the treatment of X-linked hypophosphatemia, Approved April 2018
Hematology
Andexxa (coagulation factor Xa (recombinant), inactivated-zhzo) ; Portola Pharmaceuticals;
for the reversal of factor Xa inhibitors, Approved May 2018
Doptelet (avatrombopag) ; AkaRx;
For the treatment of thrombocytopenia in adults with chronic liver disease scheduled to undergo a procedure, Approved May 2018
Lokelma (sodium zirconium cyclosilicate); AstraZeneca;
For the treatment of hyperkalemia, Approved May 2018
Palynziq (pegvaliase-pqpz) ; BioMarin;
For the treatment of phenylketonuria, Approved May 2018
Tavalisse (fostamatinib disodium hexahydrate); Rigel Pharmaceuticals;
For the treatment of chronic immune thrombocytopenia, Approved April 2018
Immunology
Ilumya (tildrakizumab-asmn); Sun Pharmaceuticals;
For the treatment of plaque psoriasis , Approved March 2018
Tavalisse (fostamatinib disodium hexahydrate); Rigel Pharmaceuticals;
For the treatment of chronic immune thrombocytopenia, Approved April 2018
Infections and Infectious Diseases
Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide); Gilead;
For the treatment of HIV-1 infection in adults, Approved February 2018
Trogarzo (ibalizumab-uiyk); TaiMed Biologics;
For the treatment of multidrug resistant HIV-1 infection, Approved March 2018
Musculoskeletal
Crysvita (burosumab-twza) ; Ultragenyx;
For the treatment of X-linked hypophosphatemia, Approved April 2018
Nephrology
Jynarque (tolvaptan); Otsuka America;
For the treatment of autosomal dominant polycystic kidney disease, Approved April 2018
Neurology
Aimovig (erenumab-aooe) ; Amgen;
For the preventive treatment of migraine in adults , Approved May 2018
Oncology
Erleada (apalutamide); Janssen Oncology;
For the treatment of prostate cancer, Approved February 2018
Lutathera (lutetium Lu 177 dotatate); Advanced Accelerator Applications;
For the treatment of gastroenteropancreatic neuroendocrine tumors, Approved January 2018
Pharmacology/Toxicology
Andexxa (coagulation factor Xa (recombinant), inactivated-zhzo) ; Portola Pharmaceuticals;
for the reversal of factor Xa inhibitors, Approved May 2018
Lucemyra (lofexidine); US Worldmeds;
For the mitigation of opioid withdrawal symptoms to facilitate abrupt opioid discontinuation in adults, Approved May 2018
Pulmonary/Respiratory Diseases
Symdeko (tezacaftor/ivacaftor) ; Vertex;
For the treatment of cystic fibrosis , Approved February 2018
Urology
Erleada (apalutamide); Janssen Oncology;
For the treatment of prostate cancer, Approved February 2018
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.
