This document lists 49 novel drugs that were approved by the FDA in 2021. It provides the drug name, active ingredient, month of approval, and intended use for each drug. Some of the drugs approved were used to treat cancers like lung cancer and lymphoma, chronic diseases like heart failure and asthma, and infectious diseases like HIV and COVID-19. The last section briefly describes two oral antiviral drugs, Paxlovid and Molnupiravir, that were approved for emergency use to treat mild to moderate cases of COVID-19 in high-risk adults.

1. NOVEL DRUG
APPROVALS
FOR
2021
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2. Sr.
No.
DRUG
NAME
ACTIVE
INGREDIENT
MONTH
(2021)
USES
1. Verquvo Vericiguat January To mitigate the risk of cardiovascular death and
hospitalization for chronic heart failure
2. Cabenuva Cabotegravir and
Rilpivirine (co-
packaged)
January To treat HIV
3. Lupkynis Voclosporin January To treat lupus nephritis
4. Tepmetko Tepotinib February To treat non-small cell lung cancer
5. Ukoniq Umbralisib February To treat marginal zone lymphoma and follicular
lymphoma
6.
7.
Evkeeza
Cosela
Evinacumab-dgnb
Trilacicilib
February
February
To treat homozygous familial
hypercholesterolemia
To mitigate chemotherapy-induced
myelosuppression in small cell lung cancer

3. Sr.
No.
DRUG
NAME
ACTIVE INGREDIENT MONTH
(2021)
USES
8. Amondys
45
Casimersen February To treat Duchenne muscular dystrophy
9. Nulibry Fosdenopterin February To reduce the risk of mortality in
cofactor deficiency Type A
10. Pepaxto Melphalan
flufenamide
February To treat relapsed or refractory multiple
myeloma
11. Azstarys Serdexmethylphenida
e and
Dexmethylphenidate
March To treat attention deficit hyperactivity disorder
12. Fotivda Tivozanib March To treat renal cell carcinoma
13. Ponvory Ponesimod March To treat relapsing forms of multiple sclerosis
14. Zegalogue Dasiglucagon March To treat severe hypoglycemia

4. Sr.
No.
DRUG
NAME
ACTIVE
INGREDIENT
MONTH
(2021)
USES
15. Qelbree Viloxazine April To treat attention deficit hyperactivity disorder
16. Nextstellis Drospirenone
and Estetrol
April To prevent pregnancy
17. Jemperli Dostarlimab-
gxly
April To treat endometrial cancer
18. Zynlonta Loncastuximab
tesirine-lpyl
April To treat certain types of relapsed or refractory large
B-cell lymphoma
19. Empaveli Pegcetacoplan May To treat paroxysmal nocturnal hemoglobinuria
20. Rybrevant Amivantamab-
vmjw
May To treat a subset of non-small cell lung cancer
21. Pylarify Piflufolastat F
18
May To identify prostate-specific membrane antigen-
positive lesions in prostate cancer

5. Sr.
No.
DRUG
NAME
ACTIVE
INGREDIENT
MONTH
(2021)
USES
22. Lumacras Sotorasib May To treat types of non-small cell lung cancer
23. Truseltiq Infigratinib May To treat cholangiocarcinoma whose disease meets
certain criteria
24. Lybalvi Olanzapine
and
Samidorphan
May To treat schizophrenia and certain aspects of bipolar I
disorder
25. Brexafemme Ibrexafunger June To treat vulvovaginal candidiasis
26. Aduhelm Aducanumab
avwa
June To treat Alzheimer’s disease
27. Rylase Asparaginase
erwinia
chrysanthemi
(recombinant
-rywn
June 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
28. Kerendia Finerenone July To reduce the risk of kidney and heart complications
in chronic kidney disease associated with type 2
diabetes

6. Sr.
No.
DRUG
NAME
ACTIVE
INGREDIENT
MONTH
(2021)
USES
29. Fexinidazol
e
Fexinidazole July To treat human African trypanosomiasis caused by
the parasite Trypanosoma brucei gambiense
30. Rezurock Belumosudil July To treat chronic graft-versus-host disease after
failure of at least two prior lines of systemic therapy
31. Bylvay Odevixibat July To treat pruritus
32. Saphnelo Anifrolumab-
fnia
July To treat moderate-to severe systemic lupus
erythematousus along with standard therapy
33. Nexviazym
e
Avalglucosidase
alfa-ngpt
August To treat late-onset Pompe disease
34. Welireg Belzutifan August To treat von Hippel-Lindau disease under certain
conditions
35. Korsuva Difelikefalin August To treat moderate-to-severe pruritus associated
chronic kidney disease in certain populations

7. Sr.
No.
DRUG
NAME
ACTIVE
INGREDIENT
MONTH
(2021)
USES
36. Skytrofa Lonapegsomatro
in-tcgd
August To treat short stature due to inadequate
of endogenous growth hormone
37. Exkivity Mobocertinib Septembe
r
To treat locally advanced or metastatic non-
cell lung cancer with epidermal growth factor
receptor exon 20 insertion mutations
38. Tivdak Tisotumab
vedotin-tftv
Septembe
r
To treat recurrent or metastatic cervical cancer
with disease progression on or after
chemotherapy
39. Qulipta Atogepant Septembe
r
To prevent episodic migraines
40. Livmarli Maralixibat Septembe
r
To treat cholestatic pruritus associated with
Alagille syndrome
41. Tavneos Avacopan October To treat severe active anti-neutrophil cytoplasmic
autoantibody-associated vasculitis (granulomatosis
polyangiitis and microscopic polyangiitis) in
combination with standard therapy, including
glucocorticoids
42. Scemblix Asciminib October To treat Philadelphia chromosome-positive
chronic myeloid leukemia with disease that

8. Sr.
No.
DRUG
NAME
ACTIVE
INGREDIENT
MONTH
(2021)
USES
43. Besremi Ropeginterferon
alfa-2b-njft
Novembe To treat polycythemia vera, a blood disease that
causes the overproduction of red blood cells
44. Voxzogo Vosoritide Novembe To improve growth in children five years of age
and older with achondroplasia and open
epiphyses
45. Livtencity Maribavir Novembe 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
46. Cytalux Pafolacianine Novembe To help identify ovarian cancer lesions
47. Tezspire Tezepelumab-
ekko
December To treat severe asthma as an add-on
maintenance therapy
48. Vyvgart Efgartigimod
alfa-fcab
December To treat generalized myasthenia gravis
49. Leqvio Inclisiran December To treat heterozygous familial
hypercholesterolemia or clinical atherosclerotic
cardiovascular disease as an add-on therapy

9. ORAL ANTIVIRAL DRUGS FOR COVID-
19 APPROVED BY USFDA
• 1. Paxlovid (Pfizer)- it consists of Nirmatevir tablets & Ritonavir tablets co packaged to
treat mild to moderate COVID- 19 in adults & pediatric patients with COVID +vity.
• 2. Molnupiravir (Merck & Ridgeback) for emergency use for treatment of mild to
moderate COVID- 19 infections in adults who are at a high risk of progression to
severe disease.

10. THANK YOU