New drug approvals - April 2024
- Please click here for a list of summary reports of benefit-risk assessments.
For the most updated information related to registered therapeutic products, please refer to the Register of Therapeutic Products.
| Product Name | IMOVAX D.T., SUSPENSION FOR INJECTION IN 0.5 ML PRE-FILLED SYRINGE |
| Active Ingredient (Strength) | Purified Diphtheria Toxoid(≥ 2 IU/ 0.5 mL),Purified Tetanus Toxoid(≥ 20 IU/ 0.5mL) |
| Application type | NDA-2: New strength/combination |
| Product Registrant | SANOFI-AVENTIS SINGAPORE PTE. LTD. |
| Date of Approval | 30/04/2024 |
| Registration No. | SIN16995P |
Indications:
Imovax d.T. is indicated for booster vaccination against tetanus and diphtheria in individuals from 6 years of age. |
| Product Name | LEDAGA TOPICAL GEL 160 ΜG /G |
| Active Ingredient (Strength) | Chlormethine hydrochloride equivalent to Chlormethine(160 μg /g ) |
| Application type | NDA-1: New chemical entity |
| Product Registrant | JUNIPER BIOLOGICS PTE LTD |
| Date of Approval | 15/04/2024 |
| Registration No. | SIN16986P |
Indications:
Ledaga is indicated for the topical treatment of mycosis fungoides-type cutaneous T-cell lymphoma (MF-type CTCL) in adult patients. |
| Product Name | NEXVIAZYME POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 100MG/VIAL |
| Active Ingredient (Strength) | AVALGLUCOSIDASE ALFA(100mg/vial) |
| Application type | NDA-1: New chemical entity |
| Product Registrant | SANOFI-AVENTIS SINGAPORE PTE. LTD. |
| Date of Approval | 24/04/2024 |
| Registration No. | SIN16989P |
Indications:
Nexviazyme (avalglucosidase alfa) is indicated for long-term enzyme replacement therapy for the treatment of patients with Pompe disease (acid α-glucosidase deficiency). |
| Product Name | TANSTRIVE HARD CAPSULES 40MG,
TANSTRIVE HARD CAPSULES 80MG |
| Active Ingredient (Strength) | Selpercatinib(40.0mg),
Selpercatinib(80.0mg) |
| Application type | NDA-1: New chemical entity
NDA-3: New strength |
| Product Registrant | DKSH SINGAPORE PTE. LTD. |
| Date of Approval | 24/04/2024 |
| Registration No. | SIN16990P,
SIN16991P |
Indications:
RET Fusion-Positive Non-Small Cell Lung Cancer
TANSTRIVE is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene fusion.
RET-Mutant Medullary Thyroid Cancer
TANSTRIVE is indicated for the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation who require systemic therapy.
RET Fusion-Positive Thyroid Cancer
TANSTRIVE is indicated for the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic thyroid cancer with a RET gene fusion who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). |
Healthcare professional, Industry member, Therapeutic Products
Published:
New Drug Approvals