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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
Source