June 20, 2021

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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?

 

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

What new drugs have been approved by FDA in Jan-Apr 2021?

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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