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The U.S Food and Drug Administration (USFDA) has approved 04 new drugs in the month of January. Out of the 04 approvals, 03 are NDA and 01 is BLA.

LEQEMBI

ITEMDESCRIPTION
NDA/BLA Number:761269
Applicant/Holder:EISAI INC
API:Lecanemab
Dosage Form:INJECTABLE/INJECTION
Strengths:500MG/5ML; 200MG/2ML
Indications:Indicated for the treatment of Alzheimer’s disease
Approval Date:06/01/2023

BRENZAVVY

ITEMDESCRIPTION
NDA/BLA Number214373
Applicant/HolderTHERAXOSBIO LLC
APIBexagliflozin
Dosage FormTABLET/ORAL
Strengths20 mg
IndicationsTo improve glycemic control in adults with type 2 diabetes mellitus as an adjunct to diet and exercise
Approval Date20/01/2023

JAYPRICA

ITEMDESCRIPTION
NDA/BLA Number216059
Applicant/HolderLOXO ONCOLOGY INC
APIPirtobrutinib
Dosage FormTABLET/ORAL
Strengths50 mg; 100 mg
IndicationsTo treat relapsed or refractory mantle cell lymphoma in adults who have had at least to lines of systemic therapy, including a BTK inhibitor
Approval Date27/01/2023

ORSERDU

ITEMDESCRIPTION
NDA/BLA Number217639
Applicant/HolderSTEMLINE THERAPEUTICS INC
APIElacestrant
Dosage FormTABLET/ORAL
Strengths345 mg; 86 mg
IndicationsTo 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
Approval Date27/01/2023



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