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  1. Drug Approvals and Databases

Drug Trials Snapshots

Contact Us at Snapshots@fda.hhs.gov

DRUG TRIALS SNAPSHOTS at a GLANCE

Drug Trials Snapshots provide consumers and healthcare professionals with concise information about who participated in the key clinical trials that supported the original FDA approval of new drugs by FDA’s Center for Drug Evaluation and Research.

  • 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 (sex, race, age, and ethnicity).

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 healthcare provider. 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.

Brand Name (Drug Trials Snapshot) Drug Name Original Date of FDA Approval FDA Approved Use on Original Approval Date* Brand Name (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
ADBRY tralokinumab-ldrm December 27, 2021 To treat moderate-to-severe atopic dermatitis Adbry
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
ADUHELM Aducanumab July 7, 2021 To treat Alzheimer’s disease Aduhelm
AEMCOLO rifamycin November 16, 2018 Treatment of traveler's diarrhea in adults Aemcolo
AGAMREE vamorolone October 26, 2023 Treatment of Duchenne muscular dystrophy Agamree
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
AMONDYS 45 casimersen February 25, 2021 Treatment of a particular type of Duchenne muscular dystrophy (DMD). It is to be used only in patients who have a specific mutation of the dystrophin gene. Amondys 45
AMVUTTRA vutrisiran June 13, 2022 To treat polyneuropathy of hereditary transthyretin-mediated amyloidosis Amvuttra
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
APHEXDA motixafortide Sepetember 8, 2023 To mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma APHEXDA
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
AZSTARYS serdexmethylphenidate and dexmethylphenidate May 7, 2021 To treat attention deficit hyperactivity disorder Azstarys
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
BESREMi  ropeginterferon alfa-2b-njft November 12, 2021 To treat polycythemia vera, a blood disease that causes the overproduction of red blood cells Besremi
BEVYXXA betrixaban June 23, 2017 Prevention of venous thromboembolism (VTE) Bevyxxa
BEYFORTUS nirsevimab July 17, 2023 Prevention of respiratory syncytial virus (RSV) lower respiratory tract disease. Beyfortus
BIKTARVY bictegravir/emtricitabine/tenofovir alafenamide February 7, 2018 Treatment of human immunodeficiency virus 1 (HIV-1) infection in adults. Biktarvy
BIMZELX bimekizumab-bkzx October 17, 2023 Treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. Bimzelx
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
BRENZAVVY  bexagliflozin January 20, 2023 To improve glycemic control in adults with type 2 diabetes mellitus as an adjunct to diet and exercise Brenzavvy
BREXAFEMME ibrexafungerp June 1, 2021 To treat vulvovaginal candidiasis Brexafemme
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
BRIUMVI ublituximab-xiiy December 28, 2022 To treat relapsing forms of multiple sclerosis Briumvi
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
BYLVAY odevixibat July 20, 2021 Treatment of pruritus. Bylvay
CABENUVA cabotegravir and rilpivirine January 20, 2021 Treatment of HIV-1 infection. Cabenuva
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 
CAMZYOS mavacamten April 28, 2022 To treat certain classes of obstructive hypertrophic cardiomyopathy Camzyos
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
CIBINQO abrocitinib January 14, 2022 Treatment of adults with refractory, moderate-to-severe atopic dermatitis Cibinqo
CINQUAIR  reslizumab March 23, 2016 Treatment of a specific type of severe asthma (called eosinophilic phenotype asthma) Cinquair
COLUMVI glofitamab-gxbm June 15, 2023 Treatment of diffuse large B-cell lymphoma, not otherwise specified, or large B-cell lymphoma arising from follicular lymphoma after two or more lines of systemic therapy Columvi
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
COSELA trilaciclib February 12, 2021 Decrease the rate of bone marrow suppression (myelosuppression) resulting from chemotherapy in adult patients when given prior to certain chemotherapy drugs (containing platinum/etoposide or topotecan) for a type of lung cancer (extensive stage-small cell lung cancer) that is widespread. Cosela
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
CYTALUX  pafolacianine November 19, 2021 To help identify ovarian cancer lesions Cytalux
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
DAXXIFY daxibotulinumtoxin A September 7, 2022 To treat moderate-to-severe glabellar lines associated with corrugator and/or procerus muscle activity. Daxxify
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
ELAHERE mirvetuximab soravtansine-gynx November 14, 2022 To treat patients with recurrent ovarian cancer that is resistant to platinum therapy Elahere
ELUCIREM gadopiclenol September 21, 2022 To detect and visualize lesions, together with MRI, with abnormal vascularity in the central nervous system and the body Elucirem
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
EMPAVELI pegcetacoplan May 14, 2021 Treatment of adults with a disease called paroxysmal nocturnal hemoglobinuria (PNH) Empaveli
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
ENJAYMO sutimlimab-jome February 4, 2022 To decrease the need for red blood cell transfusion due to hemolysis in cold agglutinin disease Enjaymo
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 
EVKEEZA evinacumab-dgnb February 11, 2021 Used along with other low-density lipoprotein (LDL) lowering medicines in people older than 12 years of age with a type of high cholesterol called homozygous familial hypercholesterolemia (HoFH). Evkeeza
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
EXKIVITY mobocertinib September 15, 2021 Treatment of adult patients with a type of lung cancer (non-small cell lung cancer or NSCLC) Exkivity
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
FEXINIDAZOLE   July 16, 2021 To treat human African trypanosomiasis caused by the parasite Trypanosoma brucei gambiense Fexinidazole
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
FOTIVDA tivozanib March 10, 2021 Treatment of adult patients with advance kidney cancer (advanced renal cell carcinoma or RCC) that has been treated with 2 or more prior medicines and has come back or did not respond to treatment. Fotivda
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, 2020 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
IMJUDO tremelimimab-actl October 21, 2022 To treat unresectable hepatocellular carcinoma Imjudo
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
JAYPIRCA pirtobrutinib January 27, 2023 To treat relapsed or refractory mantle cell lymphoma in adults who have had at least two lines of systemic therapy, including a BTK inhibitor Jaypirca
JEUVEAU efinaconazolebotulinum toxin- type A February 1, 2019 Temporary improvement of the appearance of glabellar lines (wrinkles between the eyebrows). Jeuveau
JEMPERLI dostarlimab-glxy April 22, 2021 Treatment of adult females with uterine cancer (endometrial cancer). Jemperli
JESDUVROQ daprodustat February 1, 2023 Treatment of anemia caused by chronic kidney disease for adults on dialysis for at least four months. Jesduvroq
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
KERENDIA finerenone July 9, 2021 Treatment of adults with chronic kidney disease (CKD) associated with type 2 diabetes (T2D) Kerendia
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
KIMMTRAK tebentafusp January 25, 2022 To treat unresectable or metastatic uveal melanoma Kimmtrak
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
KORSUVA Difelikefalin August 23, 2021 To treat moderate-to-severe pruritus associated with chronic kidney disease in certain populations Korsuva
KOSELUGO selumetinib April 10,2020 For the treatment of plexiform neurofibroma Koselugo
KRAZATI adagrasib December 12, 2022 Prescription medicine used to treat adult patients with non-small cell lung cancer Krazati
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
LEQVIO inclisiran December 22, 2021 To treat heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease as an add-on therapy Leqvio
LIBTAYO cemiplimab-rwlc September 25, 2018 Treatment of advanced skin cancer (squamous cell carcinoma) Libtayo
LIVMARLI maralixibat chloride September 29, 2021 To treat cholestatic pruritus associated with Alagille syndrome Livmarli
LIVTENCITY maribavir November 23, 2021 To treat post-transplant cytomegalovirus (CMV) infection/disease that does not respond (with or without genetic mutations that cause resistance) to available antiviral treatment for CMV Livtencity
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
LUMAKRAS Sotorasib May 28, 2021 For the treatment of adult patients with non-small cell lung cancer (NSCLC) that is locally advanced or has spread to other parts of the body (metastatic) Lumakras
LUMOXITI moxetumomab pasudotox-tdfk September 13, 2018 Treatment of hairy cell leukemia in adults Lumoxiti
LUNSUMIO mosunetuzumab-axgb December 22, 2022 To treat adults with relapsed or refractory follicular lymphoma, a type of non-Hodgkin lymphoma Lunsumio
LUPKYNIS voclosporin January 22, 2021 Treatment of lupus nephritis Lupkynis
LUTATHERA lutetium 177 dotate January 26, 2018 For the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) Lutathera
LYBALVI olanzapine and samidorphan May 28, 2021 For the treatment of schizophrenia and certain aspects of bipolar I disorder Lybalvi
LYTGOBI futibatinib September 30, 2022 To treat intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements Lytgobi
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
MOUNJARO tirzepatide May 13, 2022 To improve blood sugar control in diabetes, in addition to diet and exercise Mounjaro
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
NEXOBRID anacaulase-bcdb December 28, 2022 To remove charred tissue in adults with deep second degree and/or third degree burns from heat sources Nexobrid
NEXTSTELLIS estetrol and drospirenone April 15, 2021 To prevent pregnancy Nextstellis
NEXVIAZYME avalglucosidase alfa-ngpt August 6, 2021 Treatment of patients 1 year of age and older with late-onset Pompe disease (LOPD) Nexviazyme
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
NULIBRY fosdenopterin February 26, 2021 To reduce the risk of death in patients with molybdenum cofactor deficiency (MoCD) Type A. Nulibry
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 oliceridine 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
OMLONTI oomidenepag isopropyl September 22, 2022 Reduces elevated intraocular pressure in patients with open‑angle glaucoma or ocular hypertension Omlonti
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
OPDUALAG nivolumab and relatlimab-rmbw March 18, 2022 Treatment of adults and pediatric patients 12 years of age or older with a type of skin cancer called melanoma that cannot be removed by surgery (unresectable) or has spread to other parts of the body (metastatic). Opdualag
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
ORSERDU elacestrant January 27, 2023 To treat estrogen receptor-positive, human epidermal growth factor receptor 2-negative, ESR1-mutated, advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. Orserdu
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
PEPAXTO melphalan flufenamide February 26, 2021 Treatment of adults with multiple myeloma Pepaxto
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
PLUVICTO lutetium Lu 177 vipivotide tetraxetan March 23, 2022 To treat prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer following other therapies Pluvicto
POLIVY polatuzumab vedotin-piiq June 10, 2019 Treatment of adults with diffuse large B-cell lymphoma Polivy
PONVORY ponesimod March 18, 2021 Treatment of relapsing forms of multiple sclerosis (MS) Ponvory
PORTRAZZA necitumumab November 24, 2015 Treatment of metastatic squamous non-small cell lung cancer Portrazza
POSLUMA flotufolastat F 18 May 25, 2023 To detect specific cancer lesions in males with prostate cancer Posluma
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
PYLARIFY piflufolastat F 18 May 26, 2021 To identify prostate-specific membrane antigen-positive lesions in prostate cancer Pylarify
PYRUKYND mitapivat February 17, 2022 Treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency Pyrukynd
QELBREE viloxazine April 2, 2021 Treatment of attention deficit hyperactivity disorder (ADHD) in children 6 to 17 years of age Qelbree
QINLOCK ripretinib May 15, 2020 Treatment of gastrointestinal stromal tumors. Qinlock
QULIPTA atogepant September 28, 2021 To prevent episodic migraines Qulipta
QUVIVIQ daridorexant January 7, 2022 Treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance. Quvivq
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
RELYVRIO sodium phenylbutyrate and taurursodiol September 29, 2022 To treat amyotrophic lateral sclerosis (ALS) Relyvrio
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
REZLIDHIA olutasidenib December 1, 2022 Treatment of adults with relapsed or refractory acute myeloid leukemia with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation Rezlidhia
REZUROCK belumosudil July 16, 2021 To treat chronic graft-versus-host disease after failure of at least two prior lines of systemic therapy Rezurock
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
ROLVEDON eflapegrastim September 9, 2022 To decrease the incidence of infection in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia Rolvedon
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
RYBREVANT amivantamab-vmjw May 21, 2021 Treatment of adults with non-small cell lung cancer (NSCLC). Rybrevant
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
RYLAZE asparaginase erwinia chrysanthemi (recombinant)-rywn June 30, 2021 To treat acute lymphoblastic leukemia and lymphoblastic lymphoma in patients who are allergic to E. coli-derived asparaginase products, as a component of a chemotherapy regimen Rylaze
RYZODEG insulin degludec and insulin aspart injection September 26, 2015 Improves blood sugar control in adults with diabetes mellitus (DM) Ryzodeg
RYZNEUTA efbemalenograstim alfa-vuxw November 11, 2023 To treat neutropenia Ryzneuta
SAPHNELO anifrolumab-fnia July 30, 2021 To treat moderate-to severe systemic lupus erythematousus along with standard therapy Saphnelo
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  
SCEMBLIX asciminib October 29, 2021 To treat Philadelphia chromosome-positive chronic myeloid leukemia with disease that meets certain criteria Scemblix
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
SKYTROFA lonapegsomatropin-tcgd August 25, 2021 treatment of children 1 year and older who weigh at least 11.5 kilograms and are not growing because they have growth hormone deficiency (GHD) Skytrofa
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
SOTYKTU deucravacitinib September 9, 2022 To treat moderate-to-severe plaque psoriasis Sotyktu
SPEVIGO spesolimab-sbzo September 1, 2022 To treat generalized pustular psoriasis flares Spevigo
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 
SUNLENCA lenacapavir December 22, 2022 To treat adults with HIV whose HIV infections cannot be successfully treated with other available treatments due to resistance, intolerance, or safety considerations Sunlenca
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
TAVNEOS avacopan October 7, 2021 Treatment of adults with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis Tavneos
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
TECVAYLI  teclistamab-cqyv October 25, 2022 To treat relapsed or refractory multiple myeloma among adults who have received at least four specific lines of therapy Tecvayli
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
TEPMETKO tepotinib February 3, 2021 Treatment of a type of non-small cell lung cancer (NSCLC) which has a specific set of gene alterations and has spread to other parts of the body (metastatic). Tepmetko
TERLIVAZ terlipressin September 14, 2022 Treatment to improve kidney function in adults with hepatorenal syndrome (HRS) with rapid reduction in kidney function Terlivaz
TEZSPIRE Tezepelumab December 17, 2021 To treat severe asthma as an add-on maintenance therapy Tezspire
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
TIVDAK tisotumab vedotin-tftv September 20, 2021 To treat recurrent or metastatic cervical cancer with disease progression on or after chemotherapy Tivdak
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
TRUSELTIQ infigratinib May 28, 2021 To treat cholangiocarcinoma whose disease meets certain criteria Truseltiq
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
UKONIQ umbralisib February 5, 2021 Treatment of adult patients with follicular lymphoma  Ukoniq
UKONIQ umbralisib February 5, 2021 Treatment of adult patients with marginal zone lymphoma (MZL)  Ukoniq
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
VABYSMO faricimab-svoa January 28, 2022 To treat neovascular (wet) aged-related macular degeneration and diabetic macular edema Vabysmo
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
VERQUVO vericiguat January 19, 2021 Treatment of chronic heart failure Verquvo
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
VIVJOA oteseconazole April 26, 2022 To reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are not of reproductive potential Vivjoa
VIZIMPRO dacomitinib September 27, 2018 Treatment of advanced non-small cell lung cancer Vizimpro
VOQUEZNA vonoprazan fumarate, amoxicillin May 3, 2022 Treatment of Helicobacter pylori infection Voquezna
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
VOXZOGO vosoritide November 20, 2021 To improve growth in children five years of age and older with achondroplasia and open epiphyses Voxzogo
VRAYLAR cariprazine September 17, 2015 Treatment of bipolar disorder Vraylar
VRAYLAR cariprazine September 17, 2015 Treatment of schizophrenia Vraylar
VTAMA tapinarof December 7, 2023 Treatment of plaque psoriasis Vtama
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
VYVGART Vyvgart alfa-fcab December 17, 2021 For the treatment of generalized myasthenia gravis (gMG) in adult patients Vyvgart
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
WELIREG belzutifan August 13, 2021 Treatment of von Hippel-Lindau disease under certain conditions Welireg
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
XENOVIEW xenon Xe 129 hyperpolarized December 8, 2023 Evaluation of lung ventilation in adults and pediatric patients Xenoview
XENPOZYME olipudase alfa-rpcp August 31, 2023 To treat Acid Sphingomyelinase Deficiency Xenpozyme
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
ZEGALOGUE dasiglucagon March 22, 2021 To treat severe hypoglycemia Zegalogue
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
ZTALMY ganaxolone March 18, 2023 To treat seizures in cyclin-dependent kinase-like 5 deficiency disorder Ztalmy
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 
ZYNLONTA loncastuximab tesirine-lpyl April 23, 2021 To treat certain types of relapsed or refractory large B-cell lymphoma Zynlonta

* The listed “FDA-approved use” on this website is for presentation purposes only. To see the FDA-approved conditions of use [e.g., indication(s), population(s), dosing regimen(s)] for each of these products, see the most recent FDA-approved Prescribing Information.

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