New drug indication approval - June 2025
For the most updated information related to registered therapeutic products, please refer to the Register of Therapeutic Products.
| Product Name | BIKTARVY FILM-COATED TABLETS 50MG/200MG/25MG |
| Active Ingredient (Strength) | Bictegravir Sodium 52.45mg eqv Bictegravir(50mg),Emtricitabine(200mg),Tenofovir Alafenamide Fumarate 28.04mg eqv Tenofovir Alafenamide(25mg) |
| Product Registrant | GILEAD SCIENCES SINGAPORE PTE. LTD. |
| Date of Approval | 19/06/2025 |
Indications:
BIKTARVY is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients weighing at least 25 kg:
• to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no known or suspected substitutions associated with resistance to bictegravir or tenofovir. |
| Product Name | DARZALEX SC SOLUTION FOR INJECTION 1800MG/15ML |
| Active Ingredient (Strength) | Daratumumab(1800mg/15mL) |
| Product Registrant | JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD |
| Date of Approval | 03/06/2025 |
Indications:
DARZALEX® SC is indicated for the treatment of patients with multiple myeloma in combination with bortezomib, lenalidomide and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant. |
| Product Name | TAFINLAR HARD CAPSULE 50MG,
TAFINLAR DISPERSIBLE TABLET 10MG,
TAFINLAR HARD CAPSULE 75MG |
| Active Ingredient (Strength) | Dabrafenib Mesylate 59.25mg equivalent to dabrafenib(50mg),
Dabrafenib mesylate eqv Dabrafenib(10mg),
Dabrafenib Mesylate 88.88mg equivalent to dabrafenib(75mg) |
| Product Registrant | NOVARTIS (SINGAPORE) PTE LTD |
| Date of Approval | 30/06/2025 |
Indications:
Dabrafenib in combination with trametinib is indicated for the treatment of pediatric patients 1 year of age and older with high-grade glioma (HGG) with a BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options (see section 12 Clinical studies). |
| Product Name | MEKINIST® POWDER FOR ORAL SOLUTION 4.7 MG,
MEKINIST FILM-COATED TABLETS 2MG,
MEKINIST FILM-COATED TABLETS 0.5MG |
| Active Ingredient (Strength) | Trametinib dimethylsulfoxide 5.30 mg eqv trametinib(4.7 mg),
Trametinib Dimethyl Sulfoxide 2.254mg eqv trametinib(2mg),
Trametinib Dimethyl Sulfoxide 0.5635mg eqv trametinib(0.5mg) |
| Product Registrant | NOVARTIS (SINGAPORE) PTE LTD |
| Date of Approval | 30/06/2025 |
Indications:
Trametinib in combination with dabrafenib is indicated for the treatment of pediatric patients 1 year of age and older with high-grade glioma (HGG) with a BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options (see section 12 Clinical studies). |
| Product Name | BEYFORTUS SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 50 MG/ 0.5 ML,
BEYFORTUS SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 100 MG/ 1.0 ML |
| Active Ingredient (Strength) | Nirsevimab(50 mg/ 0.5 mL),
Nirsevimab(100 mg / 1.0 mL) |
| Product Registrant | SANOFI-AVENTIS SINGAPORE PTE. LTD. |
| Date of Approval | 16/06/2025 |
Indications:
Beyfortus is indicated for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season. |
Healthcare professional, Industry member, Therapeutic Products
Published:
New Drug Indication Approvals