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 |