Drug project high-priority medications: Difference between revisions

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==List of high-priority medications==
==List of high-priority medications==
=== Novel Drug Approvals for 2023 ===
{| class="wikitable"
! No. !! Drug Name !! Active Ingredient !! Approval Date !! FDA-approved use on approval date
|-
|55
|Wainua
|eplontersen
|12/21/2023
|To treat polyneuropathy of hereditary transthyretin-mediated amyloidosis
|-
|54
|Filsuvez
|birch triterpenes
|12/18/2023
|To treat wounds associated with dystrophic and junctional epidermolysis bullosa
|-
| 53 || Fabhalta || iptacopan || 12/5/2023 || To treat paroxysmal nocturnal hemoglobinuria
|-
| 52 || Ogsiveo || nirogacestat || 11/27/2023 || To treat adults with progressing desmoid tumors who require systemic treatment
|-
| 51 || Truqap || capivasertib || 11/16/2023 || To treat breast cancer that meets certain disease criteria
|-
| 50 || Ryzneuta || efbemalenograstim alfa-vuxw || 11/16/2023 || To treat neutropenia
|-
| 49 || Augtyro || repotrectinib || 11/15/2023 || To treat ROS1-positive non-small cell lung cancer
|-
| 48 || Defencath || taurolidine, heparin || 11/15/2023 || To reduce the incidence of catheter-related bloodstream infections in adults with kidney failure receiving chronic hemodialysis through a central venous catheter
|-
| 47 || Fruzaqla || fruquintinib || 11/08/23 || To treat refractory, metastatic colorectal cancer
|-
| 46 || Loqtorzi || toripalimab-tpzi || 10/27/2023 || To treat recurrent or metastatic nasopharyngeal carcinoma when used together with or following other therapies
|-
| 45 || Omvoh || mirikizumab-mrkz || 10/26/2023 || To treat ulcerative colitis
|-
| 44 || Agamree || vamorolone || 10/26/2023 || To treat Duchenne muscular dystrophy
|-
| 43 || Bimzelx || bimekizumab || 10/17/2023 || To treat moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy
|-
| 42 || Zilbrysq || zilucoplan || 10/17/2023 || To treat generalized myasthenia gravis in adults who are anti-acetylcholine receptor (AChR) antibody positive
|-
| 41 || Velsipity || etrasimod || 10/12/23 || To treat moderately to severely active ulcerative colitis in adults
|-
| 40 || Rivfloza || nedosiran || 9/29/2023 || To lower urinary oxalate levels in patients 9 years and older with primary hyperoxaluria type 1 and relatively preserved kidney function
|-
| 39 || Pombiliti || cipaglucosidase alfa-atga || 9/28/2023 || To treat late-onset Pompe disease
|-
| 38 || Exxua || gepirone || 9/22/2023 || To treat major depressive disorder
|-
| 37 || Ojjaara || momelotinib || 9/15/2023 || To treat intermediate or high-risk myelofibrosis in adults with anemia
|-
| 36 || Aphexda || motixafortide || 09/08/23 || To use with filgrastim (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma
|-
| 35 || Veopoz || pozelimab-bbfg || 8/18/2023 || To treat patients 1 year old and older with CD55-deficient protein-losing enteropathy (PLE), also known as CHAPLE disease
|-
| 34 || Sohonos || palovarotene || 8/16/2023 || 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
|-
| 33 || Elrexfio || elranatamab-bcmm || 8/14/2023 || To treat adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy
|-
| 32 || Talvey || talquetamab-tgvs || 08/09/23 || To treat adults with relapsed or refractory multiple myeloma who have received at least four prior therapies
|-
| 31 || Izervay || avacincaptad pegol || 08/04/23 || To treat geographic atrophy secondary to age-related macular degeneration
|-
| 30 || Zurzuvae || zuranolone || 08/04/23 || To treat postpartum depression
|-
| 29 || Xdemvy || lotilaner || 7/25/2023 || To treat Demodex blepharitis
|-
| 28 || Vanflyta || quizartinib || 7/20/2023 || To use as part of a treatment regimen for newly diagnosed acute myeloid leukemia that meets certain criteria
|-
| 27 || Beyfortus || nirsevimab-alip || 7/17/2023 || To prevent respiratory syncytial virus (RSV) lower respiratory tract disease
|-
| 26 || Ngenla || somatrogon-ghla || 6/27/2023 || To treat growth failure due to inadequate secretion of endogenous growth hormone
|-
| 25 || Rystiggo || rozanolixizumab-noli || 6/26/2023 || To treat generalized myasthenia gravis in adults who are anti-acetylcholine receptor- or anti-muscle-specific tyrosine kinase antibody-positive
|-
| 24 || Litfulo || ritlecitinib || 6/23/2023 || To treat severely patchy hair loss
|-
| 23 || Columvi || glofitamab-gxbm || 6/15/2023 || To treat 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
|-
| 22 || Inpefa || sotagliflozin || 5/26/2023 || To treat heart failure
|-
| 21 || Posluma || flotufolastat F 18 || 5/25/2023 || To use with positron emission tomography imaging in certain patients with prostate cancer
|-
| 20 || Paxlovid || nirmatrelvir, ritonavir || 5/25/2023 || To treat mild-to-moderate COVID-19 in adults at high risk for progression to severe COVID-19
|-
| 19 || Xacduro || sulbactam, durlobactam || 5/23/2023 || To treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex
|-
| 18 || Epkinly || epcoritamab-bysp || 5/19/2023 || 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
|-
| 17 || Miebo || perfluorhexyloctane || 5/18/2023 || To treat signs and symptoms of dry eye disease
|-
| 16 || Veozah || fezolinetant || 05/12/23 || To treat moderate to severe hot flashes caused by menopause
|-
| 15 || Elfabrio || pegunigalsidase alfa-iwxj || 05/09/23 || To treat confirmed Fabry disease
|-
| 14 || Qalsody || tofersen || 4/25/2023 || To treat amyotrophic lateral sclerosis in adults who have a SOD1 gene mutation
|-
| 13 || Joenja || leniolisib || 3/24/2023 || To treat activated phosphoinositide 3-kinase delta syndrome
|-
| 12 || Rezzayo || rezafungin || 3/22/2023 || To treat candidemia and invasive candidiasis
|-
| 11 || Zynyz || retifanlimab-dlwr || 3/22/2023 || To treat metastatic or recurrent locally advanced Merkel cell carcinoma
|-
| 10 || Daybue || trofinetide || 03/10/23 || To treat Rett syndrome
|-
| 9 || Zavzpret || zavegepant || 03/09/23 || To treat migraine
|-
|8
|Skyclarys
|omaveloxolone
|2/28/2023
|To treat Friedrich’s ataxia
|-
|7
|Filspari
|sparsentan
|2/17/2023
|To reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk of rapid disease progression
|-
|6
|Lamzede
|velmanase alfa-tycv
|2/16/2023
|To treat non-central nervous system manifestations of alpha-mannosidosis
|-
|5
|Jesduvroq
|daprodustat
|02/01/23
|To treat anemia caused by chronic kidney disease for adults on dialysis for at least four months
|-
|4
|Orserdu
|elacestrant
|1/27/2023
|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
|-
|3
|Jaypirca
|pirtobrutinib
|1/27/2023
|To treat relapsed or refractory mantle cell lymphoma in adults who have had at least two lines of systemic therapy, including a BTK inhibitor
|-
|2
|Brenzavvy
|bexagliflozin
|1/20/2023
|To improve glycemic control in adults with type 2 diabetes mellitus as an adjunct to diet and exercise
|-
|1
|Leqembi
|lecanemab-irmb
|01/06/23
|To treat Alzheimer’s disease
|}


===Novel Drug Approvals for 2022===
===Novel Drug Approvals for 2022===

Latest revision as of 04:30, 22 February 2024

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WikiDoc Drug Project — High-Priority Medications

List of high-priority medications

Novel Drug Approvals for 2023

No. Drug Name Active Ingredient Approval Date FDA-approved use on approval date
55 Wainua eplontersen 12/21/2023 To treat polyneuropathy of hereditary transthyretin-mediated amyloidosis
54 Filsuvez birch triterpenes 12/18/2023 To treat wounds associated with dystrophic and junctional epidermolysis bullosa
53 Fabhalta iptacopan 12/5/2023 To treat paroxysmal nocturnal hemoglobinuria
52 Ogsiveo nirogacestat 11/27/2023 To treat adults with progressing desmoid tumors who require systemic treatment
51 Truqap capivasertib 11/16/2023 To treat breast cancer that meets certain disease criteria
50 Ryzneuta efbemalenograstim alfa-vuxw 11/16/2023 To treat neutropenia
49 Augtyro repotrectinib 11/15/2023 To treat ROS1-positive non-small cell lung cancer
48 Defencath taurolidine, heparin 11/15/2023 To reduce the incidence of catheter-related bloodstream infections in adults with kidney failure receiving chronic hemodialysis through a central venous catheter
47 Fruzaqla fruquintinib 11/08/23 To treat refractory, metastatic colorectal cancer
46 Loqtorzi toripalimab-tpzi 10/27/2023 To treat recurrent or metastatic nasopharyngeal carcinoma when used together with or following other therapies
45 Omvoh mirikizumab-mrkz 10/26/2023 To treat ulcerative colitis
44 Agamree vamorolone 10/26/2023 To treat Duchenne muscular dystrophy
43 Bimzelx bimekizumab 10/17/2023 To treat moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy
42 Zilbrysq zilucoplan 10/17/2023 To treat generalized myasthenia gravis in adults who are anti-acetylcholine receptor (AChR) antibody positive
41 Velsipity etrasimod 10/12/23 To treat moderately to severely active ulcerative colitis in adults
40 Rivfloza nedosiran 9/29/2023 To lower urinary oxalate levels in patients 9 years and older with primary hyperoxaluria type 1 and relatively preserved kidney function
39 Pombiliti cipaglucosidase alfa-atga 9/28/2023 To treat late-onset Pompe disease
38 Exxua gepirone 9/22/2023 To treat major depressive disorder
37 Ojjaara momelotinib 9/15/2023 To treat intermediate or high-risk myelofibrosis in adults with anemia
36 Aphexda motixafortide 09/08/23 To use with filgrastim (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma
35 Veopoz pozelimab-bbfg 8/18/2023 To treat patients 1 year old and older with CD55-deficient protein-losing enteropathy (PLE), also known as CHAPLE disease
34 Sohonos palovarotene 8/16/2023 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
33 Elrexfio elranatamab-bcmm 8/14/2023 To treat adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy
32 Talvey talquetamab-tgvs 08/09/23 To treat adults with relapsed or refractory multiple myeloma who have received at least four prior therapies
31 Izervay avacincaptad pegol 08/04/23 To treat geographic atrophy secondary to age-related macular degeneration
30 Zurzuvae zuranolone 08/04/23 To treat postpartum depression
29 Xdemvy lotilaner 7/25/2023 To treat Demodex blepharitis
28 Vanflyta quizartinib 7/20/2023 To use as part of a treatment regimen for newly diagnosed acute myeloid leukemia that meets certain criteria
27 Beyfortus nirsevimab-alip 7/17/2023 To prevent respiratory syncytial virus (RSV) lower respiratory tract disease
26 Ngenla somatrogon-ghla 6/27/2023 To treat growth failure due to inadequate secretion of endogenous growth hormone
25 Rystiggo rozanolixizumab-noli 6/26/2023 To treat generalized myasthenia gravis in adults who are anti-acetylcholine receptor- or anti-muscle-specific tyrosine kinase antibody-positive
24 Litfulo ritlecitinib 6/23/2023 To treat severely patchy hair loss
23 Columvi glofitamab-gxbm 6/15/2023 To treat 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
22 Inpefa sotagliflozin 5/26/2023 To treat heart failure
21 Posluma flotufolastat F 18 5/25/2023 To use with positron emission tomography imaging in certain patients with prostate cancer
20 Paxlovid nirmatrelvir, ritonavir 5/25/2023 To treat mild-to-moderate COVID-19 in adults at high risk for progression to severe COVID-19
19 Xacduro sulbactam, durlobactam 5/23/2023 To treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex
18 Epkinly epcoritamab-bysp 5/19/2023 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
17 Miebo perfluorhexyloctane 5/18/2023 To treat signs and symptoms of dry eye disease
16 Veozah fezolinetant 05/12/23 To treat moderate to severe hot flashes caused by menopause
15 Elfabrio pegunigalsidase alfa-iwxj 05/09/23 To treat confirmed Fabry disease
14 Qalsody tofersen 4/25/2023 To treat amyotrophic lateral sclerosis in adults who have a SOD1 gene mutation
13 Joenja leniolisib 3/24/2023 To treat activated phosphoinositide 3-kinase delta syndrome
12 Rezzayo rezafungin 3/22/2023 To treat candidemia and invasive candidiasis
11 Zynyz retifanlimab-dlwr 3/22/2023 To treat metastatic or recurrent locally advanced Merkel cell carcinoma
10 Daybue trofinetide 03/10/23 To treat Rett syndrome
9 Zavzpret zavegepant 03/09/23 To treat migraine
8 Skyclarys omaveloxolone 2/28/2023 To treat Friedrich’s ataxia
7 Filspari sparsentan 2/17/2023 To reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk of rapid disease progression
6 Lamzede velmanase alfa-tycv 2/16/2023 To treat non-central nervous system manifestations of alpha-mannosidosis
5 Jesduvroq daprodustat 02/01/23 To treat anemia caused by chronic kidney disease for adults on dialysis for at least four months
4 Orserdu elacestrant 1/27/2023 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
3 Jaypirca pirtobrutinib 1/27/2023 To treat relapsed or refractory mantle cell lymphoma in adults who have had at least two lines of systemic therapy, including a BTK inhibitor
2 Brenzavvy bexagliflozin 1/20/2023 To improve glycemic control in adults with type 2 diabetes mellitus as an adjunct to diet and exercise
1 Leqembi lecanemab-irmb 01/06/23 To treat Alzheimer’s disease

Novel Drug Approvals for 2022

No. Drug Name Active Ingredient Approval Date FDA-approved use on approval date
37 NexoBrid anacaulase-bcdb 12/28/2022 To remove eschar in adults with deep partial thickness or full thickness thermal burns
36 Briumvi ublituximab-xiiy 12/28/2022 To treat relapsing forms of multiple sclerosis
35 Xenoview hyperpolarized Xe-129 12/23/2022 To evaluate pulmonary function and imaging
34 Lunsumio mosunetuzumab-axgb 12/22/2022 To treat adults with relapsed or refractory follicular lymphoma, a type of non-Hodgkin lymphoma
33 Sunlenca lenacapavir 12/22/2022 To treat adults with HIV whose HIV infections cannot be successfully treated with other available treatments due to resistance, intolerance, or safety considerationsPress Release
32 Krazati adagrasib 12/12/2022 To treat KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer in adults who have received at least one prior systemic therapy
31 Rezlidhia olutasidenib 12/1/2022 To treat adults with relapsed or refractory acute myeloid leukemia with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation
30 Tzield teplizumab-mzwv 11/18/22 To delay the onset of stage 3 type 1 diabetesPress Release
29 Elahere mirvetuximab soravtansine-gynx 11/14/2022 To treat patients with recurrent ovarian cancer that is resistant to platinum therapy
28 Tecvayli teclistamab-cqyv 10/25/2022 To treat relapsed or refractory multiple myeloma among adults who have received at least four specific lines of therapy
27 Imjudo tremelimumab 10/21/2022 To treat unresectable hepatocellular carcinoma
26 Lytgobi futibatinib 9/30/2022 To treat intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements
25 Relyvrio sodium phenylbutyrate/taurursodiol 9/29/2022 To treat amyotrophic lateral sclerosis (ALS)Press Release
24 Omlonti oomidenepag isopropyl ophthalmic solution 9/22/2022 To reduce elevated intraocular pressure in patients with open‑angle glaucoma or ocular hypertension
23 Elucirem gadopiclenol 9/21/2022 To detect and visualize lesions, together with MRI, with abnormal vascularity in the central nervous system and the body
22 Terlivaz terlipressin 9/14/2022 To improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function
21 Rolvedon eflapegrastim 9/9/2022 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
20 Sotyktu deucravacitinib 9/9/2022 To treat moderate-to-severe plaque psoriasis
19 Daxxify daxibotulinumtoixnA-lanm 9/7/2022 To treat moderate-to-severe glabellar lines associated with corrugator and/or procerus muscle activity
18 Spevigo spesolimab-sbzo 9/1/2022 To treat generalized pustular psoriasis flares
17 Xenpozyme Olipudase alfa 8/31/2022 To treat Acid Sphingomyelinase DeficiencyPress Release
16 Amvuttra vutrisiran 6/13/2022 To treat polyneuropathy of hereditary transthyretin-mediated amyloidosis
15 Vtama tapinarof 5/23/2022 To treat plaque psoriasis
14 Mounjaro tirzepatide 5/13/2022 To improve blood sugar control in diabetes, in addition to diet and exercise Press Release
13 Voquezna vonoprazan, amoxicillin, and clarithromycin 5/3/2022 To treat Helicobacter pylori infection
12 Camzyos mavacamten 4/28/2022 To treat certain classes of obstructive hypertrophic cardiomyopathy
11 Vivjoa oteseconazole 4/26/2022 To reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are not of reproductive potential
10 Pluvicto lutetium (177Lu) vipivotide tetraxetan 3/23/2022 To treat prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer following other therapies
9 Opdualag nivolumab and relatlimab-rmbw 3/18/2022 To treat unresectable or metastatic melanoma
8 Ztalmy ganaxolone 3/18/2022 To treat seizures in cyclin-dependent kinase-like 5 deficiency disorder
7 Vonjo pacritinib 2/28/2022 To treat intermediate or high-risk primary or secondary myelofibrosis in adults with low platelets
6 Pyrukynd mitapivat 2/17/2022 To treat hemolytic anemia in pyruvate kinase deficiency
5 Enjaymo sutimlimab-jome 2/4/2022 To decrease the need for red blood cell transfusion due to hemolysis in cold agglutinin disease
4 Vabysmo faricimab-svoa 1/28/2022 To treat neovascular (wet) aged-related macular degeneration and diabetic macular edema
3 Kimmtrak tebentafusp-tebn 1/25/2022 To treat unresectable or metastatic uveal melanoma
2 Cibinqo abrocitinib 1/14/2022 To treat refractory, moderate-to-severe atopic dermatitis
1 Quviviq daridorexant 1/7/2022 To treat insomnia

Novel Drug Approvals for 2021

No. Drug Name Active Ingredient Approval Date FDA-approved use on approval date
42 Scemblix asciminib 10/29/2021 To treat Philadelphia chromosome-positive chronic myeloid leukemia with disease that meets certain criteria
41 Tavneos avacopan 10/7/2021 To treat severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis (granulomatosis with polyangiitis and microscopic polyangiitis) in combination with standard therapy, including glucocorticoids
40 Livmarli maralixibat 9/29/2021 To treat cholestatic pruritus associated with Alagille syndrome
39 Qulipta atogepant 9/28/2021 To prevent episodic migraines
38 Tivdak tisotumab vedotin-tftv 9/20/2021 To treat recurrent or metastatic cervical cancer with disease progression on or after chemotherapy
37 Exkivity mobocertinib 9/15/2021 To treat locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations
36 Skytrofa lonapegsomatropin-tcgd 8/25/2021 To treat short stature due to inadequate secretion of endogenous growth hormone
35 Korsuva difelikefalin 8/23/2021 To treat moderate-to-severe pruritus associated with chronic kidney disease in certain populations
34 Welireg belzutifan 8/13/2021 To treat von Hippel-Lindau disease under certain conditions
33 Nexviazyme avalglucosidase alfa-ngpt 8/6/2021 To treat late-onset Pompe disease
32 Saphnelo anifrolumab-fnia 7/30/2021 To treat moderate-to severe systemic lupus erythematousus along with standard therapy
31 Bylvay odevixibat 7/20/2021 To treat pruritus
30 Rezurock belumosudil 7/16/2021 To treat chronic graft-versus-host disease after failure of at least two prior lines of systemic therapy
29 fexinidazole fexinidazole 7/16/2021 To treat human African trypanosomiasis caused by the parasite Trypanosoma brucei gambiense
28 Kerendia finerenone 7/9/2021 To reduce the risk of kidney and heart complications in chronic kidney disease associated with type 2 diabetes
27 Rylaze asparaginase erwinia chrysanthemi (recombinant)-rywn 6/30/2021 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
26 Aduhelm aducanumab-avwa 6/7/2021 To treat Alzheimer’s disease
25 Brexafemme ibrexafungerp 6/1/2021 To treat vulvovaginal candidiasis
24 Lybalvi olanzapine and samidorphan 5/28/2021 To treat schizophrenia and certain aspects of bipolar I disorder
23 Truseltiq infigratinib 5/28/2021 To treat cholangiocarcinoma whose disease meets certain criteria
22 Lumakras sotorasib 5/28/2021 To treat types of non-small cell lung cancer
21 Pylarify piflufolastat F 18 5/26/2021 To identify prostate-specific membrane antigen-positive lesions in prostate cancer
20 Rybrevant amivantamab-vmjw 5/21/2021 To treat a subset of non-small cell lung cancer
19 Empaveli pegcetacoplan 5/14/2021 To treat paroxysmal nocturnal hemoglobinuria
18 Zynlonta loncastuximab tesirine-lpyl 4/23/2021 To treat certain types of relapsed or refractory large B-cell lymphoma
17 Jemperli dostarlimab-gxly 4/22/2021 To treat endometrial cancer
16 Nextstellis drospirenone and estetrol 4/15/2021 To prevent pregnancy
15 Qelbree viloxazine 4/2/2021 To treat attention deficit hyperactivity disorder
14 Zegalogue dasiglucagon 3/22/2021 To treat severe hypoglycemia
13 Ponvory ponesimod 3/18/2021 To treat relapsing forms of multiple sclerosis
12 Fotivda tivozanib 3/10/2021 To treat renal cell carcinoma
11 Azstarys serdexmethylphenidate and dexmethylphenidate 3/2/2021 To treat attention deficit hyperactivity disorder
10 Pepaxto melphalan flufenamide 2/26/2021 To treat relapsed or refractory multiple myeloma
9 Nulibry fosdenopterin 2/26/2021 To reduce the risk of mortality in molybdenum cofactor deficiency Type A
8 Amondys 45 casimersen 2/25/2021 To treat Duchenne muscular dystrophy
7 Cosela trilacicilib 2/12/2021 To mitigate chemotherapy-induced myelosuppression in small cell lung cancer
6 Evkeeza evinacumab-dgnb 2/11/2021 To treat homozygous familial hypercholesterolemia
5 Ukoniq umbralisib 2/5/2021 To treat marginal zone lymphoma and follicular lymphoma
4 Tepmetko tepotinib 2/3/2021 To treat non-small cell lung cancer
3 Lupkynis voclosporin 1/22/2021 To treat lupus nephritis
2 Cabenuva cabotegravir and rilpivirine (co-packaged) 1/21/2021 To treat HIV
1 Verquvo vericiguat 1/19/2021 To mitigate the risk of cardiovascular death and hospitalization for chronic heart failure

Novel Drug Approvals for 2020

No. Drug Name Active Ingredient Approval Date FDA-approved use on approval date
53 Gemtesa vibegron 12/23/2020 To treat overactive bladder
52 Ebanga ansuvimab-zykl 12/21/2020 To treat ebola
51 Orgovyx relugolix 12/18/2020 To treat advanced prostate cancer
50 Margenza margetuximab (anti-HER2 mAb 12/16/2020 To treat HER2+ breast cancer
49 Klisyri tirbanibulin 12/14/2020 To treat actinic Keratosis of the face or scalp
48 Orladeyo berotralstat 12/3/2020 To treat patients with hereditary angioedema
47 Gallium 68 PSMA-11 Gallium 68 PSMA-11 12/1/2020 For detection and localization of prostate cancer
46 Danyelza naxitamab-gqgk 11/25/2020 To treat high-risk refractory or relapsed neuroblastoma
45 Imcivree setmelanotide 11/25/2020 To treat obesity and the control of hunger associated with pro-opiomelanocortin deficiency, a rare disorder that causes severe obesity that begins at an early age
44 Oxlumo lumasiran 11/23/2020 To treat hyperoxaluria type 1
43 Zokinvy lonafarnib 11/20/2020 To treat rare conditions related to premature aging
42 Veklury remdesivir 10/22/2020 To treat COVID-19
41 Inmazeb atoltivimab, maftivimab, and odesivimab-ebgn 10/14/2020 To treat ebola virus
40 Gavreto pralsetinib 9/4/2020 To treat non-small lung cancer
39 Detectnet copper Cu 64 dotatate injection 9/3/2020 To help detect certain types of neuroendocrine tumors
38 Sogroya somapacitan-beco 8/28/2020 Growth hormone
37 Winlevi clascoterone 8/26/2020 To treat acne
36 Enspryng satralizumab-mwge 8/14/2020 To treat neuromyelitis optica spectrum disorder
35 Viltepso viltolarsen 8/12/2020 To treat Duchenne muscular dystrophy
34 Olinvyk oliceridine 8/7/2020 To manage acute pain in certain adults
33 Evrysdi risdiplam 8/7/2020 To treat spinal muscular atrophy
32 Lampit nifurtimox 8/6/2020 To treat Chagas disease in certain pediatric patients younger than age 18
31 Blenrep belantamab mafodotin-blmf 8/5/2020 To treat multiple myeloma
30 Monjuvi tafasitamab-cxix 7/31/2020 To treat relapsed or refractory diffuse large B-cell lymphoma
29 Xeglyze abametapir 7/24/2020 To treat head lice
28 Inqovi decitabine and cedazuridine 7/7/2020 To treat adult patients with myelodysplastic syndromes
27 Rukobia fostemsavir 7/2/2020 To treat HIV
26 Byfavo remimazolam 7/2/2020 For sedation
25 Dojolvi triheptanoin 6/30/2020 To treat molecularly long-chain fatty acid oxidation disorders
24 Zepzelca lurbinectedin 6/15/2020 To treat metastatic small cell lung cancer
23 Uplizna inebilizumab-cdon 6/11/2020 To treat neuromyelitis optica spectrum disorder
22 Tauvid flortaucipir F18 5/28/2020 Diagnostic agent for patients with Alzheimer’s disease
21 Artesunate artesunate 5/26/2020 To treat severe malaria
20 Cerianna fluoroestradiol F18 5/20/2020 Diagnostic imaging agent for certain patients with breast cancer
19 Qinlock ripretinib 5/15/2020 To treat advanced gastrointestinal-stromal tumors
18 Retevmo selpercatinib 5/8/2020 To treat lung and thyroid cancers
17 Tabrecta capmatinib 5/6/2020 To treat patients with non small cell lung cancer
16 Ongentys opicapone 4/24/2020 To treat patients with Parkinson’s disease experiencing “off” episodes
15 Trodelvy sacituzumab govitecan-hziy 4/22/2020 To treat adult patients with metastatic triple-negative breast cancer who received at least two prior therapies for metastatic disease
14 Pemazyre pemigatinib 4/17/2020 To treat certain patients with cholangiocarcinoma, a rare form of cancer that forms in bile ducts
13 Tukysa tucatinib 4/17/2020 To treat advanced unresectable or metastatic HER2-positive breast cancer
12 Koselugo selumetinib 4/10/2020 To treat neurofibromatosis type 1, a genetic disorder of the nervous system causing tumors to grow on nerves
11 Zeposia ozanimod 3/25/2020 To treat relapsing forms of multiple sclerosis
10 Isturisa osilodrostat 3/6/2020 To treat adults with Cushing’s disease who either cannot undergo pituitary gland surgery or have undergone the surgery but still have the disease
9 Sarclisa isatuximab 3/2/2020 To treat multiple myloma
8 Nurtec ODT rimegepant 2/27/2020 To treat migraine
7 Barhemsys amisulpride 2/26/2020 To help prevent nausea and vomiting after surgery
6 Vyepti eptinezumab-jjmr 2/21/2020 For the preventive treatment of migraine in adults
5 Nexletol bempedoic acid 2/21/2020 To treat adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-C
4 Pizensy lactitol 2/12/2020 To treat chronic idiopathic constipation (CIC) in adults
3 Tazverik tazemetostat 1/23/2020 To treat epithelioid sarcoma
2 Tepezza teprotumumab-trbw 1/21/2020 To treat Thyroid eye disease
1 Ayvakit avapritinib 1/9/2020 To treat adults with unresectable or metastatic gastrointestinal stromal tumor (GIST)

Novel Drug Approvals for 2019

No. Drug Name Active Ingredient Approval Date FDA-approved use on approval date
48 Ubrelvy ubrogepant 12/23/2019 to treat acute treatment of migraine with or without aura in adults
47 Enhertu fam-trastuzumab deruxtecan-nxki 12/20/2019 To treat metastatic breast cancer
46 Dayvigo lemborexant 12/20/2019 To treat insomnia
45 Caplyta lumateperone tosylate 12/20/2019 To treat schizophrenia
44 TissueBlue Brilliant Blue G Ophthalmic Solution 12/20/2019 Dye used in eye surgery
43 Padcev enfortumab vedotin-ejfv 12/18/2019 To treat refractory bladder cancer
42 Vyondys 53 golodirsen 12/12/2019 To treat certain patients with Duchenne muscular dystrophy
41 Oxbryta voxelotor 11/25/2019 To treat sickle cell disease
40 Xcopri cenobamate 11/21/2019 To treat partial onset seizures
39 Givlaari givosiran 11/20/2019 To treat acute hepatic porphyria, a rare blood disorder
38 Adakveo crizanlizumab-tmca 11/15/2019 To treat patients with painful complication of sickle cell disease
37 Fetroja cefiderocol 11/14/2019 To treat patients with complicated urinary tract infections who have limited or no alternative treatment options
36 Brukinsa zanubrutinib 11/14/2019 To treat certain patients with mantle cell lymphoma, a form of blood cancer
35 Reblozyl luspatercept–aamt 11/8/2019 For the treatment of anemia in adult patients with beta thalassemia who require regular red blood cell transfusions
34 ExEm Foam air polymer-type A 11/7/2019 A diagnostic agent used to assess fallopian tube patency (openness) in women with known or suspected infertility
33 Trikafta elexacaftor/ivacaftor/tezacaftor 10/21/2019 To treat patients 12 years of age and older with the most common gene mutation that causes cystic fibrosis
32 Reyvow lasmiditan 10/11/2019 For the acute treatment of migraine with or without aura, in adults
31 fluorodopa F 18 10/10/2019 A diagnostic agent for use in positron emission tomography (PET) to help diagnose adult patients with suspected Parkinsonian syndromes (PS)
30 Scenesse afamelanotide 10/8/2019 To increase pain-free light exposure in adult patients with a history of phototoxic reactions (damage to skin) from erythropoietic protoporphyria
29 Beovu brolucizumab–dbll 10/7/2019 Treatment of wet age-related macular degeneration
28 Aklief trifarotene 10/4/2019 For the topical treatment of acne vulgaris in patients 9 years of age and older
27 Ibsrela tenapanor 9/12/2019 To treat irritable bowel syndrome with constipation in adults.
26 Nourianz istradefylline 8/27/2019 To treat adult patients with Parkinson’s disease experiencing “off” episodes
25 Ga-68-DOTATOC Ga-68-DOTATOC 8/21/2019 For use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs)
24 Xenleta lefamulin 8/19/2019 To treat adults with community-acquired bacterial pneumonia
23 Rinvoq upadacitinib 8/16/2019 To treat adults with moderately to severely active rheumatoid arthritis
22 Inrebic fedratinib 8/16/2019 To treat adult patients with intermediate-2 or high-risk primary or secondary myelofibrosis
21 Rozlytrek entrectinib 8/15/2019 To treat adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are ROS1-positive
20 Wakix pitolisant 8/14/2019 To treat excessive daytime sleepiness (EDS) in adult patients with narcolepsy
19 pretomanid 8/14/2019 For treatment-resistant forms of tuberculosis that affects the lungs
18 Turalio pexidartinib 8/2/2019 To treat adult patients with symptomatic tenosynovial giant cell tumor
17 Nubeqa darolutamide 7/30/2019 To treat adult patients with non-metastatic castration resistant prostate cancer
16 Accrufer ferric maltol 7/25/2019 To treat iron deficiency anemia in adults
15 Recarbrio imipenem, cilastatin and relebactam 7/16/2019 To treat complicated urinary tract and complicated intra-abdominal infections
14 Xpovio selinexor 7/3/2019 To treat adult patients with relapsed or refractory multiple myeloma (RRMM)
13 Vyleesi bremelanotide 6/21/2018 To treat hypoactive sexual desire disorder in premenopausal women.
12 Polivy polatuzumab vedotin-piiq 6/10/2019 To treat adult patients with relapsed or refractory diffuse large B-cell lymphoma
11 Piqray alpelisib 5/24/2019 To treat breast cancer
10 Vyndaqel tafamidis meglumine 5/3/2019 To treat heart disease (cardiomyopathy) caused by transthyretin mediated amyloidosis (ATTR-CM) in adults
9 Skyrizi risankizumab-rzaa 4/23/2019 To treat moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy
8 Balversa erdafitinib 4/12/2019 To treat adult patients with locally advanced or metastatic bladder cancer
7 Evenity romosozumab-aqqg 4/9/2019 To treat osteoporosis in postmenopausal women at high risk of fracture
6 Mayzent siponimod 3/26/2019 To treat adults with relapsing forms of multiple sclerosis
5 Sunosi solriamfetol 3/20/2019 To treat excessive sleepiness in adult patients with narcolepsy or obstructive sleep apnea
4 Zulresso brexanolone 3/19/2019 To treat postpartum depression (PPD) in adult women
3 Egaten triclabendazole 2/13/2019 To treat fascioliasis, a parasitic infestation caused by two species of flatworms or trematodes that mainly the affect the liver, sometimes referred to as “liver flukes”
2 Cablivi caplacizumab-yhdp 2/6/2019 To treat adult patients with acquired thrombotic thrombocytopenic purpura (aTTP)
1 Jeuveau prabotulinumtoxinA-xvfs 2/1/2019 For the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients
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