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
Libtayo (cemiplimab-rwlc); Regeneron Pharmaceuticals;
For the treatment of cutaneous squamous cell carcinoma, Approved September 2018
Nuzyra (omadacycline) ; Paratek Pharmaceuticals;
For the treatment of community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections, Approved October 2018
Seysara (sarecycline) ; Paratek Pharmaceuticals;
For the treatment of moderate to severe acne vulgaris in patients 9 years of age and older., Approved October 2018
Family Medicine
Aimovig (erenumab-aooe) ; Amgen;
For the preventive treatment of migraine in adults , Approved May 2018
Ajovy (fremanezumab-vfrm); Teva Pharmaceuticals;
For the treatment of migraine, Approved September 2018
Xofluza (baloxavir marboxil); Shionogi;
For the treatment of acute uncomplicated influenza , Approved October 2018
Gastroenterology
Aemcolo (rifamycin); Aries Pharmaceuticals;
For the treatment of traveler's diarrhea, Approved November 2018
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
Galafold (migalastat); Amicus Therapeutics;
For the treatment of Fabry Disease, Approved August 2018
Onpattro (patisiran); Alnylam Pharmaceuticals;
For the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults, Approved August 2018
Revcovi (elapegademase-lvlr); Leadiant Biosciences;
For the treatment of adenosine deaminase severe combined immune deficiency, Approved October 2018
Takhzyro (lanadelumab-flyo) ; Shire Pharmaceuticals;
For the prevention of hereditary angioedema attacks, Approved August 2018
Tegsedi (inotersen); Ionis Pharmaceuticals;
For the treatment of the polyneuropathy of hereditary transthyretinmediated amyloidosis in adults, Approved October 2018
Hematology
Andexxa (coagulation factor Xa (recombinant), inactivated-zhzo) ; Portola Pharmaceuticals;
for the reversal of factor Xa inhibitors, Approved May 2018
Copiktra (duvelisib); Verastem;
For the treatment of chronic lymphocytic leukemia, small lymphocytic lymphoma or follicular lymphoma, Approved September 2018
Daurismo (glasdegib); Pfizer;
For the treatment of newly-diagnosed acute myeloid leukemia in adults 75 years of age or older , Approved November 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
Lumoxiti (moxetumomab pasudotox-tdf); AstraZeneca;
For the treatment of relapsed or refractory hairy cell leukemia, Approved September 2018
Mulpleta (lusutrombopag); Shionogi;
For the treatment of thrombocytopenia in adults with chronic liver disease scheduled to undergo a procedure, Approved August 2018
Palynziq (pegvaliase-pqpz) ; BioMarin;
For the treatment of phenylketonuria, Approved May 2018
Poteligeo (mogamulizumab-kpkc); Kyowa Kirin;
For the treatment of mycosis fungoides or Sézary syndrome , Approved August 2018
Tavalisse (fostamatinib disodium hexahydrate); Rigel Pharmaceuticals;
For the treatment of chronic immune thrombocytopenia, Approved April 2018
Xospata (gilteritinib) ; Astellas;
For the treatment of acute myeloid leukemia with a FLT3 mutation, Approved November 2018
Hepatology (Liver, Pancreatic, Gall Bladder)
Mulpleta (lusutrombopag); Shionogi;
For the treatment of thrombocytopenia in adults with chronic liver disease scheduled to undergo a procedure, Approved August 2018
Immunology
Gamifant (emapalumab-lzsg); NovImmune;
For the treatment of primary hemophagocytic lymphohistiocytosis, Approved November 2018
Ilumya (tildrakizumab-asmn); Sun Pharmaceuticals;
For the treatment of plaque psoriasis , Approved March 2018
Revcovi (elapegademase-lvlr); Leadiant Biosciences;
For the treatment of adenosine deaminase severe combined immune deficiency, Approved October 2018
Takhzyro (lanadelumab-flyo) ; Shire Pharmaceuticals;
For the prevention of hereditary angioedema attacks, Approved August 2018
Tavalisse (fostamatinib disodium hexahydrate); Rigel Pharmaceuticals;
For the treatment of chronic immune thrombocytopenia, Approved April 2018
Xofluza (baloxavir marboxil); Shionogi;
For the treatment of acute uncomplicated influenza , Approved October 2018
Yupelri (revefenacin); Theravance Biopharma;
For the maintenance treatment of chronic obstructive pulmonary disease, Approved November 2018
Infections and Infectious Diseases
Aemcolo (rifamycin); Aries Pharmaceuticals;
For the treatment of traveler's diarrhea, Approved November 2018
Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide); Gilead;
For the treatment of HIV-1 infection in adults, Approved February 2018
Nuzyra (omadacycline) ; Paratek Pharmaceuticals;
For the treatment of community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections, Approved October 2018
Trogarzo (ibalizumab-uiyk); TaiMed Biologics;
For the treatment of multidrug resistant HIV-1 infection, Approved March 2018
Xofluza (baloxavir marboxil); Shionogi;
For the treatment of acute uncomplicated influenza , Approved October 2018
Internal Medicine
Tegsedi (inotersen); Ionis Pharmaceuticals;
For the treatment of the polyneuropathy of hereditary transthyretinmediated amyloidosis in adults, Approved October 2018
Musculoskeletal
Crysvita (burosumab-twza) ; Ultragenyx;
For the treatment of X-linked hypophosphatemia, Approved April 2018
Firdapse (amifampridine) ; Catalyst Pharmaceuticals;
For the treatment of Lambert-Eaton myasthenic syndrome , Approved November 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
Ajovy (fremanezumab-vfrm); Teva Pharmaceuticals;
For the treatment of migraine, Approved September 2018
Diacomit (stiripentol) ; Biocodex;
For the treatment of seizures associated with Dravet syndrome, Approved August 2018
Dsuvia (sufentanil) ; AcelRx Pharma;
For the management of acute pain, Approved November 2018
Emgality (galcanezumab-gnlm) ; Eli Lilly;
For the preventive treatment of migraine in adults , Approved September 2018
Firdapse (amifampridine) ; Catalyst Pharmaceuticals;
For the treatment of Lambert-Eaton myasthenic syndrome , Approved November 2018
Onpattro (patisiran); Alnylam Pharmaceuticals;
For the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults, Approved August 2018
Tegsedi (inotersen); Ionis Pharmaceuticals;
For the treatment of the polyneuropathy of hereditary transthyretinmediated amyloidosis in adults, Approved October 2018
Obstetrics/Gynecology (Women’s Health)
Annovera (segesterone acetate andethinylestradiolvaginal system) ; TherapeuticsMD;
For the prevention of pregnancy, Approved August 2018
Bijuva (estradiol and progesterone) ; TherapeuticsMD;
For the treatment of moderate to severe vasomotor symptoms due to menopause, Approved October 2018
Talzenna (talazoparib); Pfizer;
For the treatment of deleterious germline BRCA-mutated HER2-negative locally advanced or metastatic breast cancer, Approved October 2018
Oncology
Copiktra (duvelisib); Verastem;
For the treatment of chronic lymphocytic leukemia, small lymphocytic lymphoma or follicular lymphoma, Approved September 2018
Daurismo (glasdegib); Pfizer;
For the treatment of newly-diagnosed acute myeloid leukemia in adults 75 years of age or older , Approved November 2018
Erleada (apalutamide); Janssen Oncology;
For the treatment of prostate cancer, Approved February 2018
Libtayo (cemiplimab-rwlc); Regeneron Pharmaceuticals;
For the treatment of cutaneous squamous cell carcinoma, Approved September 2018
Lorbrena (lorlatinib); Pfizer;
For the treatment of ALK-positive metastatic non-small cell lung cancer , Approved November 2018
Lumoxiti (moxetumomab pasudotox-tdf); AstraZeneca;
For the treatment of relapsed or refractory hairy cell leukemia, Approved September 2018
Lutathera (lutetium Lu 177 dotatate); Advanced Accelerator Applications;
For the treatment of gastroenteropancreatic neuroendocrine tumors, Approved January 2018
Poteligeo (mogamulizumab-kpkc); Kyowa Kirin;
For the treatment of mycosis fungoides or Sézary syndrome , Approved August 2018
Talzenna (talazoparib); Pfizer;
For the treatment of deleterious germline BRCA-mutated HER2-negative locally advanced or metastatic breast cancer, Approved October 2018
Vitrakvi (larotrectinib); Loxo Oncology;
For the treatment of solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion, Approved November 2018
Vizimpro (dacomitinib); Pfizer;
For the treatment of metastatic non-small cell lung cancer , Approved September 2018
Xospata (gilteritinib) ; Astellas;
For the treatment of acute myeloid leukemia with a FLT3 mutation, Approved November 2018
Ophthalmology
Oxervate (cenegermin-bkbj) ; Dompe Pharmaceuticals;
For the treatment of neurotrophic keratitis, Approved August 2018
Pediatrics/Neonatology
Diacomit (stiripentol) ; Biocodex;
For the treatment of seizures associated with Dravet syndrome, Approved August 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
Lorbrena (lorlatinib); Pfizer;
For the treatment of ALK-positive metastatic non-small cell lung cancer , Approved November 2018
Nuzyra (omadacycline) ; Paratek Pharmaceuticals;
For the treatment of community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections, Approved October 2018
Symdeko (tezacaftor/ivacaftor) ; Vertex;
For the treatment of cystic fibrosis , Approved February 2018
Vizimpro (dacomitinib); Pfizer;
For the treatment of metastatic non-small cell lung cancer , Approved September 2018
Yupelri (revefenacin); Theravance Biopharma;
For the maintenance treatment of chronic obstructive pulmonary disease, Approved November 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.
