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
ITEM | DESCRIPTION | |
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
ITEM | | DESCRIPTION |
NDA/BLA Number | | 214373 |
Applicant/Holder | | THERAXOSBIO LLC |
API | | Bexagliflozin |
Dosage Form | | TABLET/ORAL |
Strengths | | 20 mg |
Indications | | To improve glycemic control in adults with type 2 diabetes mellitus as an adjunct to diet and exercise |
Approval Date | | 20/01/2023 |
JAYPRICA
ITEM | | DESCRIPTION |
NDA/BLA Number | | 216059 |
Applicant/Holder | | LOXO ONCOLOGY INC |
API | | Pirtobrutinib |
Dosage Form | | TABLET/ORAL |
Strengths | | 50 mg; 100 mg |
Indications | | To treat relapsed or refractory mantle cell lymphoma in adults who have had at least to lines of systemic therapy, including a BTK inhibitor |
Approval Date | | 27/01/2023 |
ORSERDU
ITEM | | DESCRIPTION |
NDA/BLA Number | | 217639 |
Applicant/Holder | | STEMLINE THERAPEUTICS INC |
API | | Elacestrant |
Dosage Form | | TABLET/ORAL |
Strengths | | 345 mg; 86 mg |
Indications | | 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 |
Approval Date | | 27/01/2023 |