What new drugs have been approved by FDA in Jan-Apr 2021?
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What new drugs have been approved by FDA in Jan-Apr 2021?
What new drugs have been approved by FDA in Jan-Apr 2021? one third of 2021 has passed. What are the new products in the pharmaceutical industry?
The world will pay attention to the news of the U.S. Food and Drug Administration (FDA). The FDA’s Center for Drug Evaluation and Research (CDER) is responsible for the evaluation and research of new drugs. CDER plays a decisive role in the development and evaluation of new drugs.
As of the end of April, CDER has passed 18 new drugs in 2021, excluding vaccines, blood products, nuclear immunotherapy products, etc. Among these 18 new drugs, some have never been approved before, including some new molecules, and some are similar drugs that have been previously approved. Newly approved drugs need to compete with these similar drugs.
The information of these 18 new drugs is as follows (in order of approval time):
1. Product name: VERQUVO
Ingredients: VERICIGUAT
Listed company: MERCK SHARP DOHME
Formulation and medication: tablets, oral
Date of adoption: 2021-1-19
Treatment of diseases: chronic heart failure
2. Product name: CABENUVA KIT
Composition: CABOTEGRAVIR; RILPIVIRINE
Listed company: VIIV HLTHCARE
Formulation and medication: sustained-release suspension, intramuscular injection
Date of adoption: 2021-1-21
Treatment of disease: HIV infection
3. Product name: LUPKYNIS
Composition: VOCLOSPORIN
Listed company: AURINIA
Formulation and medication: capsule, oral
Date of adoption: 2021-1-22
Treatment of disease: lupus nephropathy
4. Product name: TEPMETKO
Ingredients: TEPOTINIB HYDROCHLORIDE
Listed company: EMD SERONO INC
Formulation and medication: tablets, oral
Date of adoption: 2021-2-3
Treatment of diseases: non-small cell lung cancer
5. Product name: UKONIQ
Ingredients: UMBRALISIB TOSYLATE
Listed company: TG THERAPS
Formulation and medication: tablets, oral
Date of adoption: 2021-2-5
Treatment of diseases: patients with specific marginal zone lymphoma and follicular lymphoma
6. Trade name: EVKEEZA
Composition: EVINACUMAB-DGNB
Listed company: REGENERON PHARMACEUTICALS
Formulation and method of administration: solution, injection
Date of adoption: 2021-2-11
Treatment of diseases: homologous familial hypercholesterolemia
7. Product name: COSELA
Composition: TRILACICLIB DIHYDROCHLORIDE
Listed company: G1THERAP
Formulation and medication: powder, intravenous injection
Date of adoption: 2021-2-12
Treatment of disease: Reduce bone marrow suppression caused by chemotherapy in adult patients with small cell lung cancer
8. Product name: AMONDYS
Ingredients: CASIMERSEN
Listed company: SAREPTA THERAPS INC
Formulation and medication: solution, intravenous injection
Date of adoption: 2021-2-25
Treatment of diseases: amyotrophic lateral sclerosis
9. Product name: NULIBRY
Composition: FOSDENOPTERIN HYDROBROMIDE
Listed company: ORIGIN
Formulation and medication: powder, intravenous injection
Date of adoption: 2021-2-26
Treatment of diseases: rare genetic disease Mo cofactor deficiency type A
10. Product name: PEPAXTO
Ingredients: MELPHALAN FLUFENAMIDE HYDROCHLORIDE
Listed company: ONCOPEPTIDES AB
Formulation and medication: powder, intravenous injection
Date of adoption: 2021-2-26
Treatment of diseases: patients with specific multiple or refractory multiple myeloma
11. Product name: AZSTARYS
Ingredients: SERDEXMETHYLPHENIDATE CHLORIDE; DEXMETHYLPHENIDATE HYDROCHLORIDE
Listed company: COMMCAVE THERAPEUTICS SA
Formulation and medication: capsule, oral
Date of adoption: 2021-3-2
Treatment of disease: attention deficit hyperactivity disorder
12. Trade name: FOTIVDA
Composition: TIVOZANIB HYDROCHLORIDE
Listed company: AVEO PHARMS
Formulation and medication: capsule, oral
Date of adoption: 2021-3-10
Treatment of disease: renal cell carcinoma
13. Product name: PONVARY
Composition: PONESIMOD
Listed company: JANSSEN PHARMS
Formulation and medication: tablets, oral
Date of adoption: 2021-3-18
Treatment of disease: multiple sclerosis relapsing type
14. Product name: ZEGALOGUE
Ingredients: DASIGLUCAGON HYDROCHLORIDE
Listed company: ZEALAND PHARMA
Preparation and administration method: solution, subcutaneous injection
Date of adoption: 2021-3-22
Treatment of diseases: severe hypoglycemia
15. Product name: QELBREE
Composition: VILOXAZINE HYDROCHLORIDE
Listed company: SUPERNUS PHARMS
Formulation and medication: sustained-release capsules, oral
Date of adoption: 2021-4-2
Treatment of disease: attention deficit hyperactivity disorder
16. Product name: NEXTSTELLIS
Composition: DROSPIRENONE; ESTETROL
Listed company: MAYNE PHARMA
Formulation and medication: tablets, oral
Date of adoption: April 15, 2021
Treatment of diseases: contraceptives
17. Product name: JEMPERLI
Ingredients: DOSTARLIMAB-GXLY
Listed company: GLAXOSMITHKLINE
Formulation and medication: injection, injection
Date of adoption: 2021-4-22
Treatment of diseases: endometrial cancer
18. Product name: ZYNLONTA
Composition: LONCASTUXIMAB TESIRINE-LPYL
Listed company: ADC Therapeutics SA
Formulation and medication: injection, injection
Date of adoption: 2021-4-23
Treatment of diseases: patients with specific relapsed or refractory large B-cell lymphoma
(source:internet, reference only)
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