Drug Trials Snapshots
Contact Us at Snapshots@fda.hhs.gov
Download 2015 - 2019 Drug Trials Snapshots Summary Report (PDF - 1.5 MB)
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Download 2017 Drug Trials Snapshots Summary Report
Download 2015-2016 Drug Trials Snapshots (Text Version)
Download 2015-2016 Global Report Participation in Clinical Trials Report
DRUG TRIALS SNAPSHOTS at a GLANCE
Drug Trials Snapshots provide consumers and healthcare professionals with concise information about who participated in clinical trials that supported the FDA approval of new drugs.
- Drug Trials Snapshots are part of an overall FDA effort to make demographic data more available and transparent.
- The information in the Snapshots also highlights where the trials were conducted and whether there were any differences in the benefits and side effects among different demographic groups.
HOW TO READ SNAPSHOTS
Each Snapshot contains information about the drug in a question and answer format. Each Snapshot contains a “MORE INFO” section for more detailed and technical content.
- Consumer information is presented first.
- At the end of each consumer section of the Snapshot, there is a shaded bar with the words “MORE INFO”. This section is for anyone interested in additional information. Click the “MORE INFO” bar for more technical and detailed content including data.
- At the beginning and at the end of each Snapshot, there is a link to the drug’s Prescribing Information (formerly known as the Package Insert).
LIMITATIONS OF SNAPSHOTS
The Snapshot is simply one tool for consumers to use when discussing a drug’s risks and benefits with their physician. Do not rely on Snapshots alone to make decisions regarding medical care.
- Snapshots are not a substitute for advice from your health care professional.
- Snapshots aim to present differences in how well the drug works and side effects among different demographic groups. Conclusions regarding these differences cannot always be made.
FREQUENTLY ASKED QUESTIONS
Are all approved drugs presented in Snapshots?
No. Snapshots are published only for approved New Molecular Entities (NMEs) and original biologics. NMEs and original biologics are medications made of new molecular structures that have not been approved by the FDA before. The Snapshots program began in 2015 and reflects drugs approved after that time.
Are individual Snapshots updated?
No. The snapshots are published within 30 days of approval and contain information that was available at the time of approval.
Where can I send comments or questions about snapshots?
Comments and questions can be sent to: Snapshots@fda.hhs.gov.
| Drug Trials Snapshot | Active Ingredient | Date of FDA Approval | What is it Approved For | Prescribing Information |
|---|---|---|---|---|
| ACCRUFER | ferric maltol | July 25, 2019 | Treatment of low iron stores | Accrufer |
| ADAKVEO | crizanlizumab-tmca | November 15, 2019 | Treatment of vasooclusive crises in patients with sickle cell disease. | Adakveo |
| ADDYI | flibanserin | August 18, 2015 | Treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women | Addyi |
| ADLYXIN | lixisenatide | July 27, 2016 | Improvement of blood sugar control in adults with diabetes mellitus (DM) type 2 when used in addition to diet and exercise | Adlyxin |
| AEMCOLO | rifamycin | November 16, 2018 | Treatment of traveler's diarrhea in adults | Aemcolo |
| AIMOVIG | erenumab-aooe | May 17, 2018 | Preventive treatment of migraine in adults | Aimovig |
| AJOVY | fremanezumab-vfrm | September 14, 2018 | Preventive treatment of migraine in adults | Ajovy |
| AKLIEF | trifarotene | October 4, 2019 | For the topical treatment of acne vulgaris in patients 9 years of age and older | Aklief |
| AKYNZEO | fosnetupitant and palonosetron | April 19, 2018 | Prevention of the nausea and vomiting that happens right away or later in adults receiving certain anticancer medicines (chemotherapy) | Akynzeo |
| ALECENSA | alectinib | December 11, 2015 | Treatment of metastatic non-small cell lung cancer | Alecensa |
| ALIQOPA | copanlisib | September 14, 2017 | Treatment of adults with follicular lymphoma whose disease has come back after at least two previous treatments. | Aliqopa |
| ALUNBRIG | brigatinib | April 28, 2017 | Treatment of a type of lung cancer called non-small cell lung cancer (NSCLC) that is advanced (metastatic). | Alunbrig |
| ANNOVERA | segesterone acetate and ethinyl estradiol vaginal system | August 10, 2018 | pregnancy prevention in women | Annovera |
| ANTHIM | obiltoxaximab | March 18, 2016 | Treatment of inhalational anthrax | ANTHIM |
| ARISTADA | aripiprazole laurixil | October 5, 2015 | Treatment of schizophrenia | Aristada |
| ARTESUNATE | May 26, 2020 | Treatment on severe malaria | Artesunate | |
| ASPARLAS | calaspargase pegol-mknl | December 20, 2018 | Treatment of acute lymphoblastic leukemia (ALL) | Asparlas |
| AUSTEDO | deutetrabenazine | April 3, 2017 | Treatment of chorea in patients with Huntington’s disease. | Austedo |
| AVYCAZ | ceftazidime-avibactam | February 25, 2015 | Treatment of complicated intra-abdominal infection (abbreviated as cIAI) | Avycaz |
| AVYCAZ | ceftazidime-avibactam | February 25, 2015 | Treatment of complicated urinary tract infection (abbreviated as cUTI) | Avycaz |
| AXUMIN | fluciclovine F 18 | May 27, 2016 | Detection of prostate cancer recurrence | Axumin |
| AYVAKIT | avapritinib | January 9, 2020 | Treatment of adults with certain gastrointestinal stromal tumors | Ayvakit |
| BALVERSA | erdafitinib | April 12, 2019 | For the treatment of urothelial carcinoma (a type of bladder and urinary tract cancer) | Balversa |
| BARHEMSYS | amisulpride | February 26, 2020 | Treatment of post-operative nausea and vomiting | Barhemsys |
| BAVENCIO | avelumab | March 23, 2017 | Treatment of Merkel cell carcinoma | Bavencio |
| BAXDELA | delafloxacin | June 19, 2017 | Treatment of adult patients with bacterial skin infections. | Baxdela |
| BENZNIDAZOLE | Benznidazole | August 29, 2017 | Treatment of Chagas disease in children 2 to 12 years of age. | Benznidazole |
| BEOVU | brolucizumab-dbll | October 7, 2019 | Treatment of wet age-related macular degeneration | Beovu |
| BESPONSA | inotuzumab ozogamicin | August 17, 2017 | Treatment of adults with B-cell acute lymphoblastic leukemia (ALL). | Besponsa |
| BEVYXXA | betrixaban | June 23, 2017 | Prevention of venous thromboembolism (VTE) | Bevyxxa |
| BIKTARVY | bictegravir/emtricitabine/tenofovir alafenamide | February 7, 2018 | Treatment of human immunodeficiency virus 1 (HIV-1) infection in adults. | Biktarvy |
| BLENREP | belantamab mafodotin-blmf | August 5, 2020 | Treatment of multiple myeloma. |
Blenrep |
| BRAFTOVI | encorafenib | June 27, 2018 | Treatment of melanoma (a type of skin cancer) when used with another drug binimetinib |
Bractovi |
| BRIDION | sugammadex | December 15, 2015 | Reversal of the effects of certain neuromuscular blocking agents | Bridion |
| BRINEURA | cerliponase alfa | April 27, 2017 | Slowing loss of walking ability (ambulation) in symptomatic patients with a specific form of Batten disease. | Brineura |
| BRIVIACT | brivaracetam | February 18, 2016 | Treatment of partial-onset seizures | Briviact |
| BRUKINSA | zanubrutinib | November 14, 2019 | Treatment of adults with mantle cell lymphoma | Brukinsa |
| BYFAVO | remimazolam | July 2, 2020 | Treatment of starting and maintaining sedation in adults undergoing short (less than 30 minutes) procedures. | Byfavo |
| CABLIVI | caplacizumab-yhdp; | February 06, 2019 | Treatment of adults with an episode of acquired thrombotic thrombocytopenic purpura (aTTP) | Cablivi |
| CALQUENCE | acalabrutinib | October 31, 2017 | Treatment of mantle cell lymphoma (MCL) | Calquence |
| CAPLYTA | lumateperone | December 20, 2019 | Treatment of schizophrenia in adults. | Caplyta |
| CERIANNA | fluoroestradiol F 18 | May 20, 2020 | For the detection of estrogen receptor (ER)-positive lesions in patients with recurrent or metastatic breast cancer. | Cerianna |
| CHOLBAM | cholic acid | March 17, 2015 | Treatment of bile acid synthesis disorders due to single enzyme defects | Cholbam |
| CHOLBAM | cholic acid | March 17, 2015 | Treatment of peroxisomal disorders, including Zellweger spectrum disorders | Cholbam |
| CINQUAIR | reslizumab | March 23, 2016 | Treatment of a specific type of severe asthma (called eosinophilic phenotype asthma) | Cinquair |
| COPIKTRA | duvelisib | September 24, 2018 | Treatment of chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and follicular lymphoma (FL) | Copiktra |
| CORLANOR | ivabradine | April 15, 2015 | Reduce hospitalization from worsening heart failure. | Corlanor |
| COSENTYX | secukinumab | January 21, 2015 | Treatment of moderate to severe plaque psoriasis in adults who do not respond well to medication applied directly to the skin | Cosentyx |
| COTELLIC | (cobimetinib) | November 10, 2015 | Part of combination treatment melanoma | Cotellic |
| CRESEMBA | isavuconazonium sulfate | March 6, 2015 | Treatment of invasive aspergillosis | Cresemba |
| CRESEMBA | isavuconazonium sulfate | March 6, 2015 | Treatment of invasive mucormycosis | Cresemba |
| CRYSVITA | burosamab-twza | April 17, 2018 | For the treatment of X-linked hypophosphatemia | Crysvita |
| DAKLINZA | daclatasvir | July 24, 2015 | Treatment of chronic Hepatitis C genotype 3 infection | Daklinza |
| DALVANCE | dalbavancin hydrochloride | May 23, 2014 | Treatment of serious bacterial skin infections | Dalvance |
| DANYELZA | naxitamab-gqgk | November 25, 2020 | Treatment of high-risk neuroblastoma | Danyelza |
| DARZALEX | daratumumab | November 16, 2015 | Treatment of multiple myeloma | Darzalex |
| DAURISMO | glasdegib | November 21, 2018 | Treatment of adults with newly-diagnosed acute myeloid leukemia (AML). | Daurismo |
| DAYVIGO | lemborexant | December 20, 2019 | Treatment of adults with insomnia. | Dayvigo |
| DEFITELIO | defibrotide sodium | March 30, 2016 | Treatment of hepatic veno-occlusive disease (VOD) | Defitelio |
| DETECTNET | copper Cu 64 dotatate | September 3, 2020 | Detection of tumors called somatostatin receptor positive neuro-endocrine tumors (NETs). | |
| DIACOMIT | stiripentol | August 20, 2018 | Treatment of seizures in patients with Dravet syndrome | Diacomit |
| DOJOLVI | triheptanoin | June 30, 2020 | Source of calories and fatty acids for patients with long-chain fatty acid oxidation disorders | Dojolvi |
| DOPTELET | avatrombopag | May 21, 2018 | Treatment of adults with low platelet count | Doptelet |
| DUPIXENT | dupilumab | March 28, 2017 | Treatment of moderate to severe atopic dermatitis in adults | Dupixent |
| EBANGA | ansuvimab-zykl | December 21, 2020 | Treatment of Zaire ebolavirus infection | Ebanga |
| EGATEN | triclabendazole | February 13, 2019 | Treatment of fasciolasis | Egaten |
| ELZONRIS | tagraxofusp-erzx | December 21, 2018 | Treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN | Elzonris |
| EMFLAZA | deflazacort | February 9, 2017 | Treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and older | Emflaza |
| EMGALITY | galcanezumab-gnim | September 27, 2018 | Preventive treatment of migraine in adults | Emgality |
| EMPLICITI | elotuzumab | November 30, 2015 | Treatment of multiple myeloma | Empliciti |
| ENHERTU | fam-trastuzumab deruxtecan-nxki | December 20, 2019 | Metastatic HER2-positive breast cancer in adults | Enhertu |
| ENSPRYNG | satralizumab-mwge | August 14, 2020 | Treatment ofnneuromyelitis optica spectrum disorder (NMOSD) | Enspryng |
| ENTRESTO | sacubitril/valsartan | July 7, 2015 | Treatment of heart failure | Entresto |
| ENTYVIO | vedolizumab | May 20, 2014 | Treatment of Crohn’s Disease | Entyvio |
| ENTYVIO | vedolizumab | May 20, 2014 | Treatment of Ulcerative Colitis | Entyvio |
| EPCLUSA | sofosbuvir and velpatasvir | June 28, 2016 | Treatment of chronic Hepatitis C virus genotypes 1, 2, 3, 4, 5 or 6 infection. | Epclusa |
| EPIDIOLEX | cannabidiol | June 25, 2018 | Treatment of seizures in two rare and severe forms of epilepsy. | Epidiolex |
| ERLEADA | apalutamide | February 14, 2018 | Treatment of prostate cancer that has not spread to other parts of the body (non-metastatic) | Erleada |
| EUCRISA | crisaborole | December 14, 2016 | Treatment of mild to moderate atopic dermatitis in patients 2 age years of age and older | Eucrisa |
| EVENITY | romosozumab-aqqg | April 9, 2019 | For the treatment of osteoporosis in women after menopause | Evenity |
| EVRYSDI | risdiplam | August 7, 2020 | For the treatment of spinal muscular atrophy (SMA) | Evrysdi |
| EXEM FOAM | air polymer-Type A | November 7, 2019 | Detection of fallopian tubes patency (openness) in women with infertility | Exem Foam |
| EXONDYS 51 | eteplirsen | September 19, 2016 | Treatment of particular type of Duchenne muscular dystrophy | Exondys 51 |
| FARYDAK | panobinostat | February 23, 2015 | Treatment of multiple myeloma | Farydak |
| FASENRA | benralizumab | November 14, 2017 | Treatment of a specific type of severe asthma (called eosinophilic phenotype asthma) | Fasenra |
| FETROJA | cefiderocol | November 14, 2018 | For the treatment of a complicated urinary tract infection. | Fetroja |
| FIRDAPSE | amifampridine | November 28, 2018 | Treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults. | Firdapse |
| FLUORODOPA F 18 | October 10, 2019 | Visual detection of certain nerve cells in adult patients with suspected Parkinsonian Syndromes (PS). | Fluorodopa f 18 | |
| Ga-68-DOTATOC | August 21, 2019 | Detection of of tumors called somatostatin receptor positive neuro-endocrine tumors (NETs) | Ga-68-dotatoc | |
| Ga 68 PSMA-11 | December 1, 2010 | Detection of specific cancer lesions in men with prostate cancer | Ga 68 PSMA-11 | |
| GALAFOLD | migalastat hydrochloride | August 10, 2018 | Treatment of Fabry disease in adults | Galafold |
| GAMIFANT | emapalumab-lzsg | November 20, 2018 | Treatment of patients with primary hemophagocytic lymphohistiocytosis | Gamifant |
| GAVRETO | pralsetinib | September 4, 2020 | Treatment of non-small cell lung cancer | Gavreto |
| GEMTESA | vibegron | December 23, 2020 | Treatment of symptoms of overactive bladder | Gemtesa |
| GENVOYA | elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide | November 5, 2015 | Complete regimen for the treatment of HIV-1 in adults and children 12 years of age and older. | Genvoya |
| GIAPREZA | angiotensin II | December 21, 2017 | Used to increase dangerously low blood pressure in adults with certain types of shock. | Giapreza |
| GIVLAARI | givosiran | November 20, 2019 | For the treatment of adults with acute hepatic porphyria (AHP). | Givlaari |
| HEMLIBRA | emicizumab | November 16, 2017 | Prevent ion or reduction of bleeding episodes in adults and children with hemophilia A. | Hemlibra |
| IBRANCE | palbociclib | February 3, 2015 | Treatment of a specific form of advanced breast cancer called ER-positive, HER2-negative (ER+/HER-) breast cancer in women who have gone through menopause (post-menopausal) | Ibrance |
| IBSRELA | tenapanor | September 12, 2019 | Irritable bowel syndrome with constipation | Ibsrela |
| IDHIFA | enasidenib | August 1, 2017 | Treatment of adults with acute myeloid leukemia (AML) that have a mutation in a gene called IDH2 and whose disease has come back or has not improved after previous treatment(s). | IDHIFA |
| ILUMYA | tildrakizumab-asmn | March 20, 2018 | For the treatment of moderate to severe plaque psoriasis | Ilumya |
| IMCIVREE | setmelanotide | May 1, 2017 | Treatment of obesity in patients 6 years and older with rare disorder | Imcivree |
| IMFINZI | durvalumab | May 1, 2017 | Treatment of a type of bladder and urinary tract cancer called urothelial carcinoma. | Imfinzi |
| INGREZZA | valbenazine | April 11, 2017 | Treatment of tardive dyskinesia | Ingrezza |
| INMAZEB | atoltivimab, maftivimab, and odesivimab-ebgn | October 14, 2020 | Treatment of Zaire ebolavirus (Ebola virus) infection | Inmazeb |
| INQOVI | decitabine and cedazuridine | July 7, 2020 | Treatment of adults with myelodysplastic syndromes (MDS) including chronic myelomonocytic leukemia. | Inqovi |
| INREBIC | fedratinib | August 16, 2019 | Treatment of myelofibrosis | Inrebic |
| ISTURISA | osilodrostat | March 6, 2020 | Treatment of Cushing's disease | Isturisa |
| JEUVEAU | efinaconazolebotulinum toxin- type A | February 1, 2019 | Temporary improvement of the appearance of glabellar lines (wrinkles between the eyebrows). | Jeuveau |
| JUBLIA | efinaconazole | June 6, 2014 | Treatment of fungal infection of the toenails due to two common forms of fungi | Jublia |
| KANUMA | sebelipase alfa | December 8, 2015 | Treatment of Lysosomal Acid Lipase (LAL) deficiency | Kanuma |
| KENGREAL | cangrelor | June 22, 2015 | Prevention of coronary artery blood clot formation in patients undergoing PCI | Kengreal |
| KEVZARA | sarilumab | May 22, 2017 | Treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) | Kevzara |
| KISQALI | ribociclib | March 13, 2017 | Treatment of a specific form of advanced breast cancer | Kisqali |
| KLISYRI | tirbanibulin | December 14, 2020 | Treatment of actinic keratosis | Klisyri |
| KOSELUGO | selumetinib | April 10,2020 | For the treatment of plexiform neurofibroma | Koselugo |
| KRINTAFEL | tafenoquine | July 20, 2018 | Prevention of malaria relapse caused by the parasite, Plasmodium vivax | Krintafel |
| KYBELLA | deoxycholic acid | April 29, 2015 | Treatment for double chin | Kybella |
| LAMPIT | nifurtimox | August 6, 2020 | Treatment of Chagas disease | Lampit |
| LARTRUVO | olaratumab | October 19, 2016 | Treatment of soft tissue sarcoma | Lartruvo |
| LENVIMA | lenvatinib | February 13, 2015 | Treatment of progressive, differentiated thyroid cancer (DTC) that can no longer be treated with radioactive iodine | Lenvima |
| LIBTAYO | cemiplimab-rwlc | September 25, 2018 | Treatment of advanced skin cancer (squamous cell carcinoma) | Libtayo |
| LOKELMA | sodium zirconium cyclosilicate | May 18, 2018 | Treatment of hyperkalemia in adults | Lokelma |
| LONSURF | trifluridine and tipiracil | September 22, 2015 | Treatment of advanced colorectal cancer | Lonsurf |
| LORBRENA | lorlatinib | November 2, 2018 | Treatment of specific type of lung cancer | Lorbrena |
| LUCEMYRA | lofexidine hydrochloride | May 16, 2018 | For the treatment of symptoms associated with opioid withdrawal during abrupt opioid discontinuation. | Lucemyra |
| LUMOXITI | moxetumomab pasudotox-tdfk | September 13, 2018 | Treatment of hairy cell leukemia in adults | Lumoxiti |
| LUTATHERA | lutetium 177 dotate | January 26, 2018 | For the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) | Lutathera |
| MACRILEN | macimorelin acetate | December 20, 2017 | Diagnosis of growth hormone deficiency in adults | Macrilen |
| MARGENZA | margetuximab-cmkb | December 16, 2020 | Treatment of metastatic breast cancer | Margenza |
| MAVYRET | glecaprevir and pibrentasvir | August 3, 2017 | Treatment of adults who have a specific type of hepatitis C virus (HCV) infection, called chronic hepatitis C virus genotypes 1, 2, 3, 4, 5 or 6 infection | Mavyret |
| MAYZENT | siponimod | March 26, 2019 | For treatment of adults with relapsing forms of multiple sclerosis | Mayzent |
| MEKTOVI | binimetinib | June 27, 2018 | Treatment of melanoma (a type of skin cancer) when used with another drug encorafenib. | Mektovi |
| MEPSEVII | vestronidase alfa-vjbk | November 15, 2017 | Treatment of Mucopolysaccharidosis VII (MPS, VII, Sly syndrome) | Mepsevii |
| MONJUVI | tafasitamab-cxix | July 31, 2020 | For the treatment of diffuse large B-cell lymphoma (DLBCL) | Monjuvi |
| MOTEGRITY | prucalopride | December 14, 2018 | Treatment of chronic idiopathic constipation (CIC) in adults. | Motegrity |
| MOXIDECTIN | moxidectin | June 13, 2018 | Treatment of onchocerciasis in patients 12 years of age and older | Moxidectin |
| MULPLETA | lusutrombopag | July 31, 2018 | Treatment of adults with low platelet count | Mulpleta |
| NATPARA | parathyroid hormone | January 23, 2015 | Control of hypocalcemia along with calcium and vitamin D in adults with hypoparathyroidism | Natpara |
| NERLYNX | neratinib | July 17, 2017 | Treatment of an early stage HER2 -positive breast cancer. | Nerlynx |
| NETSPOT | kit for the preparation of gallium Ga 68 dotatate injection | June 1, 2016 | Detection of a specific type of tumors called somatostatin receptor positive neuro-endocrine tumors (NETs) | Netspot |
| NEXLETOL | bempedoic acid | February 21, 2020 | Treatment of high LDL cholesterol | Nexletol |
| NINLARO | ixazomib | November 20, 2015 | Treatment of multiple myeloma | Ninlaro |
| NOURIANZ | istradefylline |
August 27, 2019 | Treatment of “off episodes” in patients with Parkinson’s disease | Nourianz |
| NUBEQA | darolutamide | July 30, 2019 | Treatment of prostate cancer | Nubeqa |
| NUCALA | mepolizumab | November 4, 2015 | Treatment of a specific type of severe asthma (called eosinophilic phenotype asthma) | Nucala |
| NUPLAZID | pimavanserin | April 29, 2016 | Treatment of hallucinations and delusions in patients with Parkinson’s disease | Nuplazid |
| NURTEC ODT | rimegepant | February 27, 2020 | Treatment of acute migraine | Nurtec Odt |
| NUZYRA | omadacycline | October 2, 2018 | Treatment of community-acquired bacterial pneumonia (CABP) | Nuzyra |
| OCALIVA | obeticholic acid | May 27, 2016 | Treatment of primary biliary cholangitis in adults | Ocaliva |
| ODOMZO | sonidegib | July 24, 2015 | Treatment of locally advanced basal cell carcinoma | Odomzo |
| OCREVUS | ocrelizumab | March 28, 2017 | Treatment of patients with two types of multiple sclerosis | Ocrevus |
| OLINVYK | baricitinib | August 7, 2020 | For the treatment of acute pain | Olinvyk |
| OLUMIANT | baricitinib | May 31, 2018 | Treatment of adult patients with rheumatoid arthritis (RA) whose disease was not well controlled using RA medications called Tumor Necrosis Factor (TNF) antagonists | Olumiant |
| OMEGAVEN | fish oil triglycerides | July 27, 2018 | Treatment of Parenteral nutrition-associated cholestasis (PNAC) | Omegaven |
| ONGENTYS | opicapone | April 24,2018 | Treatment of “off episodes” in patients with Parkinson’s disease | Ongentys |
| ONPATTRO | patisiran | August 10, 2018 | Treatment of nerve damage in adult patients with hereditary tranthyretin-mediated amyloidosis | Onpattro |
| ORGOVYX | relugolix | December 18, 2020 | Treatment of advanced prostate cancer | Orgovyx |
| ORILISSA | elagolix | July 23, 2018 | Treatment of moderate to severe pain associated with endometriosis | Orilissa |
| ORKAMBI | lumacaftor/ivacaftor | July 2, 2015 | Treatment of cystic fibrosis | Orkambi |
| ORLADEYO | berotralstat | December 3, 2020 | Prevention of attacks of hereditary angioedema (HAE) in patients 12 years and older. | Orladeyo |
| OXBRYTA | voxelotor | November 25, 2019 | Treatment of sickle cell disease. | Oxbryta |
| OXERVATE | cenegermin-bkbj | August 22, 2018 | Treatment of neurotrophic keratitis | Oxervate |
| OXLUMO | lumasiran | November 23, 2018 | Lowering the level of urine oxalate in children and adults with primary hyperoxaluria type 1 (PH1). | Oxlumo |
| OZEMPIC | semaglutide | December 5, 2017 | Improvement of blood sugar control in adults with type 2 diabetes mellitus (DM) when used in addition to diet and exercise. | Ozempic |
| PADCEV | enfortumab vedotin-ejfv | December 13, 2019 | For the treatment of a type of bladder and urinary tract cancer called urothelial carcinoma. | Padcev |
| PALYNZIG | pegvaliase-pqpz | May 24, 2018 | Lowering the blood levels of phenylalanine in adults with phenylketonuria (PKU) | Palynziq |
| PARSABIV | etelcalcetide | February 7, 2017 | Treat high levels of parathyroid hormone (PTH) | Parsabiv |
| PEMAZYRE | pemigatinib | April 17, 2020 | Treatment of adults with metastatic bile duct cancer (cholangiocarcinoma) | Pemazyre |
| PIFELTRO | doravirine | August 30, 2018 | Treatment of HIV-1 infection in adults | Pifeltro |
| PIQRAY | alpelisib | May 24, 2019 | Treatment of advanced breast cancer | Piqray |
| PIZENSY | lactitol | February 12, 2020 | Treatment of a type of constipation called chronic idiopathic constipation (CIC) | Pizensy |
| POLIVY | polatuzumab vedotin-piiq | June 10, 2019 | Treatment of adults with diffuse large B-cell lymphoma | Polivy |
| PORTRAZZA | necitumumab | November 24, 2015 | Treatment of metastatic squamous non-small cell lung cancer | Portrazza |
| POTELIGEO | mogamulizumab-kpkc | August 8, 2018 | Treatment of adults with mycosis fungoides or Sézary syndrome | Poteligeo |
| PRALUENT | alirocumab | July 24, 2015 | Treatment of certain patients with high cholesterol | Praluent |
| PRAXBIND | idarucizumab | October 16, 2015 | Reversal of the anticoagulant effects of Pradaxa during emergency situations or when there is a need to reverse its blood-thinning effects | Praxbind |
| PRETOMANID | August 14, 2019 | Treatment of lung tuberculosis in limited population | Pretomanid | |
| PREVYMIS | letermovir | November 8, 2017 | Prevention of cytomegalovirus (CMV) infection and disease in adults | Prevymis |
| QINLOCK | ripretinib | May 15, 2020 | Treatment of gastrointestinal stromal tumors. | Qinlock |
| RADICAVA | edaravone | May 5, 2017 | Treatment of Amyotrophic Lateral Sclerosis (ALS) | Radicava |
| REBLOZYL | luspatercept-aamt | November 8, 2019 | For the treatment of anemia in adult patients with beta thalassemia | Reblozyl |
| RECARBRIO | imipenem, cilastatin, and relebactam | July 16, 2019 | Treatment of complicated urinary tract infection | Recarbrio |
| REPATHA | evolocumab | August 27, 2015 | Treatment of certain patients with high cholesterol | Repatha |
| RETEVMO | selpercatinib | May 8, 2020 | Treatment of certain cancers caused by abnormal RET (rearranged during transfection) genes | Retevmo |
| REVCOVI | evolocumab | October 5, 2018 | Treatment of adenosine deaminase severe combined immune deficiency. | Revcovi |
| REXULTI | brexpiprazole | July 10, 2015 | Treatment of major depressive disorder | Rexulti |
| REYVOW | lasmiditan | October 11, 2019 | Treatment of acute migraine with or without aura, in adults | Reyvow |
| RHOPRESSA | netarsudil | December 18, 2017 | Reducing elevated intraocular pressure, when the pressure inside the eye is too high | Rhopressa |
| RINVOQ | upadacitinib | August 16, 2019 | Treatment for rheumatoid arthritis | Rinvoq |
| ROZLYTREK | entrectinib | August 15, 2019 | Treatment of non-small cell lung cancer | Rozlytrek |
| ROZLYTREK | entrectinib | August 15, 2019 | Treatment of certain types of solid tumors | Rozlytrek |
| RUBRACA | rucaparib | December 19, 2016 | Treatment of women with certain type of advanced ovarian cancer | Rubraca |
| RUKOBIA | fostemsavir | July 2, 2020 | Treatment of HIV infection in patients with limited treatment options. | Rukobia |
| RYDAPT | midostaurin | April 28, 2017 | Treatment of adults with acute myeloid leukemia (AML) that has a mutation in a gene called FLT3, in combination with chemotherapy | Rydapt |
| RYDAPT | midostaurin | April 28, 2017 | Treatment of adults with advanced systemic mastocytosis (SM) | Rydapt |
| RYZODEG | insulin degludec and insulin aspart injection | September 26, 2015 | Improves blood sugar control in adults with diabetes mellitus (DM) | Ryzodeg |
| SARCLISA | isatuximab-irfc | March 2, 2020 | Treatment of multiple myeloma | Sarclisa |
| SAVAYSA | edoxaban | January 8, 2015 | Prevention of stroke in patients with atrial fibrillation | Savaysa |
| SCENESSE | afamelanotide | October 08, 2019 | Increasing pain-free light exposure in adult patients with a history of phototoxic reactions (damage to skin) from erythropoietic protoporphyria | Scenesse |
| SEYSARA | sarecycline | October 1, 2018 | For the treatment of certain types of acne vulgaris in patients 9 years and older | Seysara |
| SILIQ | brodalumab | February 15, 2017 | SILIQ is used for treatment of moderate to severe plaque psoriasis in adults | Siliq |
| SIVEXTRO | tedizolid | June 20, 2014 | Treatment of serious bacterial skin infections known as acute bacterial skin and skin structure infections | Sivextro |
| SKYRIZI | risankizumab-rzaa | April 23, 2019 | Treatment of moderate to severe plaque psoriasis | Skyrizi |
| SOGROYA | somapacitan-beco | August 28, 2020 | Replacement of growth hormone in adults with growth hormone deficiency (GHD). | Sogroya |
| SOLOSEC | secnidazole | September 15, 2017 | Used to treat adult women with vaginal infections caused by bacteria known as bacterial vaginosis | Solosec |
| SPINRAZA | nusinersen | December 23, 2016 | Treatment of spinal muscular atrophy | SPINRAZA |
| STEGLATRO | ertugliflozin | December 19, 2017 | Improvement of blood sugar control in adults with type 2 diabetes when used in addition to diet and exercise. | Steglatro |
| STIOLTO RESPIMAT | tiotropium bromide and olodaterol | May 21, 2015 | Long-term treatment of COPD | Stiolto Respimat |
| STRENSIQ | asfotase alfa | October 23, 2015 | Treatment of perinatal, infantile and juvenile-onset hypophosphatasia (HPP) | Strensiq |
| SUNOSI | solriamfetol | March 20, 2018 | To improve wakefullness in adults with narcolepsy or obstructive sleep apnea (OSA) | Sunosi |
| SYMDEKO | tezacaftor/ivacaftor | February 12, 2018 | For the treatment of cystic fibrosis | Symdeko |
| SYMPROIC | naldemedine | March 23, 2017 | Treatment for adults with constipation caused by prescription pain drugs called opioids | Symproic |
| TABRECTA | capmatinib | May 6, 2020 | Treatment of non-small cell lung cancer (NSCLC) | Tabrecta |
| TAGRISSO | osimertinib | November 13, 2015 | Treatment of patients with advanced non-small cell lung cancer (NSCLC) | Tagrisso |
| TAKHZYRO | lanadelumab-flyo | August 23, 2018 | Prevent attacks of hereditary angioedema in people 12 years and older | Takhzyro |
| TALZENNA | talazoparib | October 16, 2018 | Treatment of adults with a specific form of breast cancer | Talzenna |
| TALTZ | ixekizumab | March 22, 2016 | Treatment of moderate to severe plaque psoriasis in adults | Taltz |
| TAUVID | flortaucipir F 18 | March 28, 2020 | To visually detect aggregated neurofibrillary tangles in the brain of patients with Alzheimer's | Tauvid |
| TAVALISSE | fostamatinib disodium hexahydrate | April 17, 2018 | Treatment of adults with low platelet count due to chronic immune thrombocytopenia (ITP) | Tavalisse |
| TAZVERIK | tazemetostat | January 23, 2020 | Treatment of advanced epithelioid sarcoma | Tazverik |
| TECENTRIQ | atezolizumab | May 18, 2016 | Treatment of a type of bladder cancer called urothelial carcinoma | Tecentriq |
| TEGSEDI | inotersen | October 5, 2018 | Treatment of nerve damage in adult patients with hereditary transthyretin-mediated amyloidosis | Tegsedi |
| TEPEZZA | teprotumumab-trbw | January 21, 2020 | Treatment of thyroid eye disease. | Tepezza |
| TIBSOVO | ivosidenib | July 20, 2018 | Treatment of adults with acute myeloid leukemia (AML) that have a mutation in a gene called IDH1 and whose disease has come back or has not improved after previous treatment(s) | Tibsovo |
| TISSUEBLUE | Brilliant Blue G Ophthalmic Solution | December 20, 2019 | Drug used to stain the internal limiting membrane (ILM) | Tissueblue |
| TPOXX | tecovirimat | July 13, 2018 | Treatment of smallpox disease | Tpoxx |
| TREMFYA | guselkumab | July 13, 2017 | treatment of moderate to severe plaque psoriasis in adults | Tremfya |
| TRESIBA | insulin degludec injection | September 25, 2015 | Improve glucose control in adults with diabetes mellitus | Tresiba |
| TRIKAFTA | elexacaftor/tezacaftor/ivacaftor; ivacaftor | October 21, 2019 | Treatment of patients 12 years of age and older with the most common gene mutation that causes cystic fibrosi. | Trikafta |
| TRODELVY | sacituzumab govitecan-hziy | April 22, 2020 | Treatment of breast cancer | Trodelvy |
| TROGARZO | ibalizumab-uiyk | March 6, 2018 | Treatment of human immunodeficiency virus 1 (HIV-1) infection in adults | Trogarzo |
| TRULANCE | plecanatide | January 19, 2017 | Treatment of chronic idiopathic constipation in adults | Trulance |
| TUKYSA | tucatinib | April 17, 2020 | Treatment of breast cancer | Tukysa |
| TURALIO | pexidartinib | August 2, 2019 | Treatment of tenosynovial giant cell tumor | Turalio |
| TYMLOS | abaloparatide | April 28, 2017 | Treatment of postmenopausal women with osteoporosis who are at high risk for bone fracture | Tymlos |
| UBRELVY | ubrogepant | December 23, 2019 | Treatment of migraine with or without aura | UBRELVY |
| ULTOMIRIS | ravulizumab-cwvz | December 21, 2018 | Treatment of paroxysmal nocturnal hemoglobinuria (PNH) | Ultomiris |
| UNITUXIN | dinutuximab | March 10, 2015 | Treatment of children with high-risk neuroblastoma | Unituxin |
| UPLIZNA | inebilizumab-cdon | June 11, 2020 | For the treatment of neuromyelitis optica spectrum disorder (NMOSD) | Uplizna |
| UPTRAVI | selexipag | December 21, 2015 | Treatment of adults with pulmonary artery hypertension | Uptravi |
| VABOMERE | meropenem and vaborbactam | August 29, 2017 | Treatment of adults who have a complicated urinary tract infection (abbreviated as cUTI) | Vabomere |
| VARUBI | rolapitant | September 1, 2015 | Prevent delayed phase chemotherapy-induced nausea and vomiting | Varubi |
| VEKLURY | remdesivir | October 22, 2020 | Treatment of COVID-19 | Veklury |
| VELTASSA | patiromer | October 21, 2015 | Treatment of hyperkalemia | Veltassa |
| VENCLEXTA | venetoclax | April 11, 2016 | Treatment of chronic lymphocytic leukemia (CLL) | Venclexta |
| VERZENIO | abemaciclib | September 28, 2017 | Treatment of specific forms of breast cancer | Verzenio |
| VIBERZI | eluxadoline | May 27, 2015 | Treatment of irritable bowel syndrome with diarrhea | Viberzi |
| VILTEPSO | viltolarsen | August 12, 2020 | For the treatment of a particular type of Duchenne muscular dystrophy (DMD). | Viltepso |
| VISTOGARD | uridine triacetate | December 11, 2015 | Emergency treatment of an overdose with fluorouracil or capecitabine | Vistogard |
| VITRAKVI | larotrectinib | November 26, 2018 | Treatment of tumors with specific biomarker | Vitrakvi |
| VIZIMPRO | dacomitinib | September 27, 2018 | Treatment of advanced non-small cell lung cancer | Vizimpro |
| VOSEVI | sofosbuvir,velpatasvir and voxilaprevir | July 18, 2017 | Treatment of adults who have a specific type of hepatitis C virus (HCV) infection, called chronic hepatitis C virus genotypes 1, 2, 3, 4, 5 or 6 infection | Vosevi |
| VRAYLAR | cariprazine | September 17, 2015 | Treatment of bipolar disorder | Vraylar |
| VRAYLAR | cariprazine | September 17, 2015 | Treatment of schizophrenia | Vraylar |
| VYEPTI | eptinezumab-jjmr | February 21, 2020 | Treatment of migraines | Vyepti |
| VYLEESI | bremelanotide injection | June 21, 2019 | Treatment of women with hypoactive sexual desire disorder | Vyleesi |
| VYNDAQEL/VYNDAMAX | VYNDAQEL(tafamidis meglumine)/ VYNDAMAX (tafamidis) | May 03, 2019 | Treatment of the cardiomyopathy caused by transthyretin‑mediated amyloidosis (ATTR-CM) | Vyndaqel |
| VYONDYS 53 | golodirsen | December 12, 2019 | For the treatment of a particular type of Duchenne muscular dystrophy (DMD) | Vyondys 53 |
| VYZULTA | latanoprostene bunod | November 2, 2017 | Reducing elevated intraocular pressure (IOP) | Vyzulta |
| WAKIX | pitolisant | August 14, 2019 | Treatment of excessive sleepiness due to narcolepsy. | Wakix |
| WINLEVI | clascoterone | August 26, 2020 | For the treatment of acne vulgaris. | Winlevi |
| XENLETA | lefamulin | August 19, 2019 | Treatment of community-acquired bacterial pneumonia (CABP) | Xenleta |
| XADAGO | safinamide | March 21, 2017 | Treatment of “off episodes” in patients with Parkinson’s disease | Xadago |
| XCOPRI | cenobamate | November 21, 2019 | Treatment of partial-onset seizures in adult patients | Xcopri |
| XEGLYZE | abametapir | July 24, 2020 | Treatment of head lice | Xeglyze |
| XEPI | ozenoxacin | December 11,2017 | treatment of impetigo due to certain bacteria | Xepi |
| XERAVA | eravacycline | August 27, 2018 | complicated intra-abdominal infections caused by bacteria in patients 18 years and older | Xerava |
| XERMELO | telotristat ethyl | February 28, 2017 | Treatment of diarrhea in adult patients with carcinoid syndrome | Xermelo |
| XIIDRA | lifitegrast | July 11, 2016 | Treatment of the signs and symptoms of dry eye disease. | Xiidra |
| XOFLUZA | baloxavir marboxil | November 24, 2018 | Treatment of the flu (influenza) in people 12 years of age and older | Xofluza |
| XOSPATA | gilteritinib | November 28, 2018 | Treatment of acute myeloid leukemia (AML) with a FLT3 mutation | Xospata |
| XPOVIO | selinexor | July 3, 2019 | Treatment of multiple myeloma | Xpovio |
| XURIDEN | uridine triacetate | September 4, 2015 | Treatment of patients with hereditary orotic aciduria | Xuriden |
| YONDELIS | trabectedin | October 23, 2015 | Treatment of certain types of advances tissue sarcoma | Yondelis |
| YUPELRI | revefenacin | November 9, 2018 | Maintenance treatment of adults with a lung disease called COPD | Yupelri |
| ZEJULA | niraparib | March 27, 2017 | Treatment of adult patients with recurrent ovarian cancer, fallopian tube cancer, or primary peritoneal cancer | Zejula |
| ZEMDRI | plazomicin | June 25, 2018 | Treatment of adults who have a complicated urinary tract infection | Zemdri |
| ZEPATIER | elbasvir and grazoprevir | January 28, 2016 | Treatment of chronic Hepatis C genotypes 1 or 4 infection | Zepatier |
| ZEPOSIA | ozanimod | March 25, 2020 | Treatment of multiple sclerosis | Zeposia |
| ZEPZELCA | lurbinectedin | June 15, 2020 | Treatment of small cell lung cancer | Zepzelca |
| ZINBRYTA | daclizumab | May 27, 2016 | Treatment of relapsing forms of multiple sclerosis (MS) | Zinbryta |
| ZINPLAVA | bezlotoxumab | October 21, 2016 | Decreasing the risk of Clostridium difficile infection recurrence | Zinplava |
| ZOKINVY | lonafarnib | November 20, 2020 | To treat rare conditions related to premature aging | Zokinvy |
| ZONTIVITY | vorapaxar | May 8, 2014 | Reduction of heart attacks and stroke in high-risk patients | Zontivity |
| ZULRESSO | brexanolone | March 19, 2019 | Treatment of postpartum depression | Zulresso |
| ZURAMPIC | lesinurad | December 22, 2015 | Lowering uric acid levels in the blood of adult patients with gout | Zurampic |
Related Information
- Who's in Clinical Trials?
- CDER Conversations: Drug Trials Snapshots
- FDA Basics Webinar - April 27, 2015: Drug Trials Snapshots
- New Drugs at FDA: CDER’s New Molecular Entities and New Therapeutic Biological Products
Resources For You
- Inside Clinical Trials: Testing Medical Products in People
- The FDA's Drug Review Process: Ensuring Drugs Are Safe and Effective
- CDER Drug Approval Case Study (PDF - 636 KB)