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.

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

Xerava (eravacycline) ; Tetraphase Pharmaceuticals; For the treatment of complicated intra-abdominal

infections , Approved August 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

Jivi (antihemophilic factor [recombinant] PEGylated-aucl); Bayer; For hemophilia A, Approved August
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

Tibsovo (ivosidenib); Agios Pharmaceuticals; For the treatment of acute myeloid leukemia with a
susceptible IDH1 mutation, Approved July 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

Delstrigo (doravirine, lamivudine, and tenofovir disoproxil fumarate) ; Merck; For the treatment of HIV-1
infection, Approved August 2018

Nuzyra (omadacycline) ; Paratek Pharmaceuticals; For the treatment of community-acquired bacterial

pneumonia and acute bacterial skin and skin structure infections, Approved October 2018

Pifeltro (doravirine) ; Merck; For the treatment of HIV-1 infection, Approved August 2018

Symtuza (darunavir, cobicistat, emtricitabine, and tenofovir alafenamide); Janssen Therapeutics; For the
treatment of HIV-1 infection, Approved July 2018

Tpoxx (tecovirimat); Siga Technologies; For the treatment of smallpox , Approved July 2018

Trogarzo (ibalizumab-uiyk); TaiMed Biologics; For the treatment of multidrug resistant HIV-1 infection,
Approved March 2018
Xerava (eravacycline) ; Tetraphase Pharmaceuticals; For the treatment of complicated intra-abdominal
infections , Approved August 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

Tibsovo (ivosidenib); Agios Pharmaceuticals; For the treatment of acute myeloid leukemia with a
susceptible IDH1 mutation, Approved July 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