Drug Trials Snapshots
Contact Us at Snapshots@fda.hhs.gov
Download 2023 Drug Trials Snapshots Summary Report
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Download 2022 Drug Trials Snapshots Summary Report
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Download 2020 Drug Trials Snapshots Summary Report
Download 2015 - 2019 Drug Trials Snapshots Summary Report
Download 2019 Drug Trials Snapshots Summary Report
Download 2018 Drug Trials Snapshots Summary Report
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 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) |
|---|---|---|---|---|
| MIPLYFFA | arimoclomol | September 20, 2024 | To treat Niemann-Pick disease type C | Miplyffa |
| AQNEURSA | levacetylleucine | September 24, 2024 | Treatment of Niemann-Pick disease type C | Aqneursa |
| NIKTIMVO | axatilimab-csfr | August 14, 2024 | To treat chronic graft-versus-host disease (cGVHD) | Niktimvo |
| EBGLYSS | lebrikizumab-lbkz | September 13, 2024 | An interleukin-13 antagonist indicated for the treatment of adult and pediatric patients 12 years of age and older | Ebglyss |
| LUMISIGHT | pegulicianine | April 17, 2024 | To use as an optical imaging agent for the detection of cancerous tissue | Lumisight |
| MIEBO | perfluorohexyloctane ophthalmic solution | May 18, 2023 | Treatment for patients with the signs and symptoms of dry eye disease (DED) | Miebo |
| 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 |
| ANKTIVA | nogapendekin alfa inbakicept-pmnl | April 22, 2024 | To treat a subtype of non-muscle invasive bladder cancer (NMIBC), called carcinoma in situ (CIS) | Anktivia |
| 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 |
| AUGTYRO | repotrectinib | November 15, 2023 | To treat ROS1-positive non-small cell lung cancer | Augtyro |
| 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 |
| DAYBUE | trofinetide | March 12, 2023 | To treat Rett syndrome. | Daybue |
| DAYVIGO | lemborexant | December 20, 2019 | Treatment of adults with insomnia. | Dayvigo |
| DEFENCATH | taurolidine, heparin | November 15, 2023 | To reduce the incidence of catheter-related bloodstream infections in adults with kidney failure receiving chronic hemodialysis through a central venous catheter. | Defencath |
| 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 |
| DUVYZAT | givinostat | March 21, 2024 | Treatment of Duchenne muscular dystrophy in individuals aged 6 years and older | Duvyzat |
| 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 |
| ELFABRIO | pegunigalsidase alfa-iwx | May 9, 2023 | An enzyme replacement therapy that is used for the treatment of Fabry disease in adult patients. | Elfabrio |
| ELREXFIO | elranatamab-bcmm | August 14, 2023 | To treat adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy | Elrexfio |
| 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 |
| EPKINLY | epcoritamab-bysp | May 19, 2023 | To treat relapsed or refractory diffuse large B-cell lymphoma (not otherwise specified) and high-grade B-cell lymphoma after two or more lines of systemic therapy | Epkinly |
| 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 |
| EXBLIFEP | cefepime and enmetazobactam | February 22, 2024 | For the treatment of patients 18 years and older with complicated urinary tract infections (cUTI) | Exblifep |
| 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 |
| FABHLATA | iptacopan | December 5, 2023 | Treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH) | Fabhlata |
| 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 | |
| FILSPARI | sparsentan | February 17, 2023 | To reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk of rapid disease progression | Filspari |
| FILSUVEZ | birch triterpenes | December 18, 2023 | To treat wounds associated with dystrophic and junctional epidermolysis bullosa | Filsuvez |
| 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 |
| FRUZAQLA | fruquintinib | November 8, 2023 | To treat refractory, metastatic colorectal cancer | Fruzaqla |
| 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 |
| INPEFA | sotagliflozin | May 26, 2023 | Treatment of heart failure | Inpefa |
| 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 |
| IQIRVO | elafibranor | June 10, 2024 | To treat primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA or as monotherapy in patients unable to tolerate UDCA | iqirvo |
| ISTURISA | osilodrostat | March 6, 2020 | Treatment of Cushing's disease | Isturisa |
| IZERVAY | avacincaptad pegol intravitreal solution | August 4, 2023 | To treat geographic atrophy secondary to age-related macular degeneration | Izervay |
| 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 |
| JOENJA | leniolisib | March 24, 2023 | Treatment of activated phosphoinositide 3-kinase delta syndrome. | Joenja |
| 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 |
| KISUNLA | donanemab-azbt | July 2, 2024 | To treat people with Alzheimer’s disease | Kisunla |
| 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 |
| LAMZEDE | velmanase alfa-tycv | February 16, 2023 | To treat non-central nervous system manifestations of alpha-mannosidosis | Lamzede |
| 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 |
| LEQEMBI | lecanemab-irmb | January 6, 2023 | Treatment of Alzheimer’s disease | Leqembi |
| LEQSELVI | deuruxolitinib | July 25, 2024 | Indicated for the treatment of adults with severe alopecia areata (AA). | Leqselvi |
| LEQVIO | inclisiran | December 22, 2021 | To treat heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease as an add-on therapy | Leqvio |
| LETYBO | letibotulinumtoxinA | February 29, 2024 | To temporarily improve the appearance of moderate-to-severe glabellar lines | Letybo |
| LIBTAYO | cemiplimab-rwlc | September 25, 2018 | Treatment of advanced skin cancer (squamous cell carcinoma) | Libtayo |
| LIVDELZI | seladelpar | August 14, 2024 | To treat primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA or as monotherapy in patients unable to tolerate UDCA. | Livdelzi |
| 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 |
| NEMLUVIO | nemolizumab-ilto | August 12, 2024 | To treat prurigo nodularis | Nemluvio |
| 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 |
| NGENLA | somatrogon-ghla | June 27, 2023 | Treatment of growth failure due to inadequate secretion of endogenous growth hormone | Ngenla |
| 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 |
| OGSIVEO | nirogacestat | November 27, 2023 | To treat adults with progressing desmoid tumors who require systemic treatment | Ogsiveo |
| OHTUVAYRE | ensifentrine | June 26, 2024 | For the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients. | Ohtuvayre |
| OJEMDA | tovorafenib | April 23, 2024 | To treat certain types of brain tumors (cancers) called gliomas in patients 6 months and older | Ojemda |
| OJJAARA | momelotinib | September 15, 2023 | to treat a rare type of bone marrow disorder called myelofibrosis (MF) in adults with anemia | Ojjaara |
| 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 |
| PAXLOVID | nirmatrelvir, ritonavir | May 25, 2023 | To treat mild-to-moderate COVID-19 in adults at high risk for progression to severe COVID-19 | Paxlovid |
| 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 |
| PIASKY | crovalimab-akkz | June 20, 2024 | Treatment of paroxysmal nocturnal hemoglobinuria | Piasky |
| 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 |
| POMBILITI | cipaglucosidase alfa-atga | September 28, 2023 | the treatment of adult patients with late-onset Pompe disease (LOPD) | Pombiliti Opfolda |
| 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 | Praxbindpfolda |
| 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 |
| QALSODY | tofersen | April 25, 2023 | Treatment of amyotrophic lateral sclerosis in adults who have a SOD1 gene mutation | Qalsody |
| 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 |
| REZDIFFRA | resmetirom | March 14, 2024 | To treat adults with nonalcoholic steatohepatitis (NASH) with moderate to advanced liver scarring (fibrosis), but not with cirrhosis of the liver. | Rezdiffra |
| 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 |
| REZZAYO | rezafungin for injection | March 22, 2023 | To treat candidemia and invasive candidiasis | Rezzayo |
| 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 |
| RIVFLOZA | nedosiran | September 29, 2023 | To lower urinary oxalate levels in patients 9 years and older with primary hyperoxaluria type 1 and relatively preserved kidney function | Rivfloza |
| 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 |
| RYSTIGGO | rozanolixizumab-noli | June 26, 2023 | To treat generalized myasthenia gravis in adults who are anti-acetylcholine receptor- or anti-muscle-specific tyrosine kinase antibody-positive | Rystiggo |
| RYTELO | imetelsta | June 6, 2024 | to treat a condition called low- to intermediate-1 risk myelodysplastic syndromes (MDS) in adults with anemia | Rytelo |
| 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 |
| SKYCLARYS | omaveloxolone | February 28, 2023 | To treat Friedrich’s ataxia | Skyclarys |
| 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 |
| SOFDRA | sofpironium bromide | June 18, 2024 | An anticholinergic antiperspirant approved for primary axillary hyperhidrosis in adult and pediatric patients 9 years of age and older. | Sofdra |
| SOGROYA | somapacitan-beco | August 28, 2020 | Replacement of growth hormone in adults with growth hormone deficiency (GHD). | Sogroya |
| SOHONOS | palovarotene | August 16, 2023 | To reduce the volume of new heterotopic ossification in adults and pediatric patients (aged 8 years and older for females and 10 years and older for males) with fibrodysplasia ossificans progressiva | Sohonos |
| 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 |
| TALVEY | talquetamab-tgvs | August 10, 2023 | To treat a form of blood cancer called multiple myeloma | Talvey |
| 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 |
| TEVIMBRA | tislelizumab-jsgr | March 14, 2024 | To treat unresectable or metastatic esophageal squamous cell carcinoma | Tevimbra |
| 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 |
| TRUQAP | capivasertib | November 16, 2023 | To treat breast cancer that meets certain disease criteria | Truqap |
| 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 |
| TZIELD | teplizumab-mzwv | November 17, 2022 | Used to delay the onset of type 1 diabetes in children and adults who are at high risk for type 1 diabetes | Tzield |
| 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 |
| VAFSEO | vadadustat | March 27, 2024 | To treat anemia due to chronic kidney disease | Vafseo |
| VANFLYTA | quizartinib | July 20, 2023 | To use as part of a treatment regimen for newly diagnosed acute myeloid leukemia that meets certain criteria | Vanflyta |
| VARUBI | rolapitant | September 1, 2015 | Prevent delayed phase chemotherapy-induced nausea and vomiting | Varubi |
| VEKLURY | remdesivir | October 22, 2020 | Treatment of COVID-19 | Veklury |
| VELSIPITY | etrasimod | October 12, 2023 | To treat moderately to severely active ulcerative colitis in adults | Velsipity |
| VELTASSA | patiromer | October 21, 2015 | Treatment of hyperkalemia | Veltassa |
| VENCLEXTA | venetoclax | April 11, 2016 | Treatment of chronic lymphocytic leukemia (CLL) | Venclexta |
| VEOPOZ | pozelimab-bbfg | August18, 2023 | To treat patients 1 year old and older with CD55-deficient protein-losing enteropathy (PLE), also known as CHAPLE disease | Veopoz |
| VEOZAH | fezolinetant | May 12, 2023 | To treat moderate to severe hot flashes caused by menopause | Veozah |
| 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 |
| VONJO | pacritinib | February 28, 2022 | To treat adult patients with a rare type of bone marrow disorder called myelofibrosis with platelet counts below 50,000/µL. | VONJO |
| VOQUEZNA | vonoprazan fumarate, amoxicillin | May 3, 2022 | Treatment of Helicobacter pylori infection | Voquezna |
| VORANIGO | vorasidenib | August 6, 2024 | Treatment of Grade 2 astrocytoma or oligodendroglioma | Voranigo |
| 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 |
| VOYDEYA | danicopan | March 29, 2024 | To treat extravascular hemolysis with paroxysmal nocturnal hemoglobinuria | Voydeya |
| 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 |
| VYLOY | zolbetuximab-clzb | October 18, 2024 | To treat gastric or gastroesophageal junction adenocarcinoma | Vyloy |
| 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 |
| WAINUA | eplontersen | December 21, 2023 | To treat polyneuropathy of hereditary transthyretin-mediated amyloidosis | Wainua |
| 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 |
| WINREVAIR | sotatercept-csrk | March 26, 2024 | For the treatment of adults with pulmonary arterial hypertension | Winrevair |
| XACDURO | sulbactam for injection; durlobactam for injection | May 23, 2023 | Treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex | Xacduro |
| 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 |
| XDEMVY | lotilaner ophthalmic solution | July 24, 2023 | To treat Demodex blepharitis, a type of eyelid infection. | xdemvy |
| 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 |
| XOLREMDI | mavorixafor | April 26, 2024 | For the treatment of adults and adolescents over the age of 12 years with WHIM (Warts, Hypogammaglobulinemia, Infection, and Myelokathexis) syndrome | Xolremdi |
| 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 |
| YORVIPATH | palopegteriparatide | August 9, 2024 | To treat hypoparathyroidism | Yorvipath |
| YUPELRI | revefenacin | November 9, 2018 | Maintenance treatment of adults with a lung disease called COPD | Yupelri |
| ZAVZPRET | zavegepant | March 9, 2023 | To treat migraine | Zavzpret |
| 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 |
| ZELSUVMI | berdazimer | January 5, 2024 | Treatment of molluscum contagiosum | Zelsuvmi |
| 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 |
| ZEVTERA | ceftobiprole medocaril sodium for injection | April 3, 2024 | Treatment of certain bloodstream infections, bacterial skin and associated tissue infections, and community-acquired bacterial pneumonia | Zevtera |
| ZILBRYSQ | zilucoplan | October 17, 2023 | To treat generalized myasthenia gravis in adults who are anti-acetylcholine receptor (AChR) antibody positive | Zilbrysq |
| 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 |
| ZURZUVAE | zuranolone | August 4, 2023 | To treat postpartum depression | Zurzuvae |
| 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.
Related Information
- 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