New drug indication approval - May 2025
For the most updated information related to registered therapeutic products, please refer to the Register of Therapeutic Products.
| Product Name | TAGRISSO TABLET 40MG,
TAGRISSO TABLET 80MG |
| Active Ingredient (Strength) | Osimertinib mesylate 47.7mg eqv Osimertinib(40mg),
Osimertinib mesylate 95.4mg eqv Osimertinib(80mg) |
| Product Registrant | ASTRAZENECA SINGAPORE PTE LTD |
| Date of Approval | 13/05/2025 |
Indications:
TAGRISSO (osimertinib) as monotherapy is indicated for the treatment of patients with locally advanced, unresectable (stage III) NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations and whose disease has not progressed during or following platinum-based chemoradiation therapy. *Evaluated as part of Project Orbis. |
| Product Name | ENHERTU POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 100MG/VIAL |
| Active Ingredient (Strength) | Trastuzumab deruxtecan(100 mg/vial) |
| Product Registrant | ASTRAZENECA SINGAPORE PTE LTD |
| Date of Approval | 29/05/2025 |
Indications:
ENHERTU as a monotherapy is indicated for the treatment of adult patients with unresectable or metastatic hormone receptor-positive HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer who have received at least one endocrine therapy in the metastatic setting. |
| Product Name | REBLOZYL POWDER FOR SOLUTION FOR INJECTION 25 MG/VIAL,
REBLOZYL POWDER FOR SOLUTION FOR INJECTION 75 MG/VIAL |
| Active Ingredient (Strength) | Luspatercept(25 MG/vial),
Luspatercept(75.0 MG/vial) |
| Product Registrant | BRISTOL-MYERS SQUIBB (SINGAPORE) PTE. LTD. |
| Date of Approval | 19/05/2025 |
Indications:
Reblozyl is indicated in adults for the treatment of anemia associated with transfusion-dependent and non-transfusion-dependent beta-thalassaemia (see section 5.1). |
| Product Name | VERASEAL SOLUTIONS FOR SEALANT, 80 MG/ML, 500 IU/ML |
| Active Ingredient (Strength) | Human Fibrinogen(80 mg/ml),Human Thrombin(500 IU/ml) |
| Product Registrant | GRIFOLS ASIA PACIFIC PTE. LTD. |
| Date of Approval | 29/05/2025 |
Indications:
Veraseal is indicated as supportive treatment where standard surgical techniques are insufficient.
-for improvement of haemostasis
-as suture support: in vascular surgery |
| Product Name | RYBREVANT CONCENTRATE FOR SOLUTION FOR INFUSION 350MG/7ML |
| Active Ingredient (Strength) | Amivantamab(350mg/7ml) |
| Product Registrant | JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD |
| Date of Approval | 27/05/2025 |
Indications:
RYBREVANT® is indicatedin combination with carboplatin and pemetrexed for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal-growth factor receptor (EGFR) exon 20 insertion mutations. *Evaluated as part of Project Orbis. |
| Product Name | TRECONDI POWDER FOR SOLUTION FOR INFUSION 1 G PER VIAL,
TRECONDI POWDER FOR SOLUTION FOR INFUSION 5 G PER VIAL |
| Active Ingredient (Strength) | Treosulfan(1 g / vial),
Treosulfan(5 g / vial) |
| Product Registrant | LINK HEALTHCARE SINGAPORE PTE LTD |
| Date of Approval | 13/05/2025 |
Indications:
Treosulfan in combination with fludarabine is indicated as part of conditioning treatment prior to allogeneic haematopoietic stem cell transplantation (alloHSCT) in adult patients with acute myeloid leukaemia (AML) or myelodysplastic syndrome (MDS) at increased risk of toxicity with standard conditioning therapies, and in paediatric patients older than one month with malignant and non-malignant diseases. |
| Product Name | VFEND FILM-COATED TABLET 50 MG,
VFEND FOR INFUSION 200 MG/VIAL,
VFEND POWDER FOR ORAL SUSPENSION 40MG/ML,
VFEND FILM-COATED TABLET 200 MG |
| Active Ingredient (Strength) | Voriconazole(50 mg),
Voriconazole(10 mg/ml),
Voriconazole(40mg/ml),
Voriconazole(200 mg) |
| Product Registrant | PFIZER PRIVATE LIMITED |
| Date of Approval | 21/05/2025 |
Indications:
Prophylaxis in patients who are at high risk of developing invasive fungal infections, such as haematopoietic stem cell transplant (HSCT) recipients. |
| Product Name | TALZENNA CAPSULE 0.25MG |
| Active Ingredient (Strength) | Talazoparib tosylate eqv Talazoparib(0.25 mg) |
| Product Registrant | PFIZER PRIVATE LIMITED |
| Date of Approval | 21/05/2025 |
Indications:
TALZENNA is indicated in combination with enzalutamide for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) in whom chemotherapy is not clinically indicated. |
| Product Name | PRALUENT SOLUTION FOR INJECTION IN A PRE-FILLED PEN 75MG/ML,
PRALUENT SOLUTION FOR INJECTION IN A PRE-FILLED PEN 150 MG/ML |
| Active Ingredient (Strength) | Alirocumab(75 mg/ml),
Alirocumab(150 mg/ml) |
| Product Registrant | SANOFI-AVENTIS SINGAPORE PTE. LTD. |
| Date of Approval | 15/05/2025 |
Indications:
Primary hypercholesterolaemia and mixed dyslipidaemia
Praluent is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, and in paediatric patients 8 years of age and older with heterozygous familial hypercholesterolaemia (HeFH) as an adjunct to diet:
- in combination with a statin or statin with other lipid lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin or,
- alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated. |
| Product Name | SARCLISA CONCENTRATE FOR SOLUTION FOR INFUSION 20MG/ML |
| Active Ingredient (Strength) | ISATUXIMAB(20mg/mL) |
| Product Registrant | SANOFI-AVENTIS SINGAPORE PTE. LTD. |
| Date of Approval | 15/05/2025 |
Indications:
Sarclisa is indicated in combination with bortezomib, lenalidomide, and dexamethasone, for the treatment of adult patients with newly diagnosed active multiple myeloma who are not eligible for autologous stem cell transplant (ASCT). *Evaluated via Access |
Healthcare professional, Industry member, Therapeutic Products
Published:
New Drug Indication Approvals