New drug approvals - February 2025
- 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 | ELFABRIO CONCENTRATE FOR SOLUTION FOR INFUSION 2 MG/ML |
|---|
| Active Ingredient (Strength) | Pegunigalsidase alfa(2 mg/ml) |
| Application type | NDA-1: New biological entity |
| Product Registrant | ORIENT EUROPHARMA PTE LTD |
| Date of Approval | 20/02/2025 |
| Registration No. | SIN17186P |
Indications:
ELFABRIO is indicated for the treatment of adults with confirmed Fabry disease. |
| Product Name | HYMPAVZI SOLUTION FOR INJECTION IN SINGLE-DOSE PRE-FILLED PEN 150 MG/ML |
|---|
| Active Ingredient (Strength) | Marstacimab(150 mg/ml) |
| Application type | NDA-1: New biological entity |
| Product Registrant | PFIZER PRIVATE LIMITED |
| Date of Approval | 27/02/2025 |
| Registration No. | SIN17187P |
Indications:
HYMPAVZI is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and paediatric patients 12 years of age and older with: ∙ severe haemophilia A (congenital factor VIII deficiency) without factor VIII inhibitors, or
∙ severe haemophilia B (congenital factor IX deficiency) without factor IX inhibitors Evaluated via Access |
| Product Name | RYKINDO EXTENDED-RELEASE INJECTABLE SUSPENSION 25MG/VIAL,
RYKINDO EXTENDED-RELEASE INJECTABLE SUSPENSION 37.5MG/VIAL,
RYKINDO EXTENDED-RELEASE INJECTABLE SUSPENSION 50MG/VIAL |
|---|
| Active Ingredient (Strength) | Risperidone(25mg/vial),
Risperidone(37.5mg/vial),
Risperidone(50mg/vial) |
| Application type | NDA-2/3: New presentation |
| Product Registrant | LUYE PHARMA (SINGAPORE) PTE. LTD. |
| Date of Approval | 20/02/2025 |
| Registration No. | SIN17183P,
SIN17184P,
SIN17185P |
Indications:
RYKINDO® is indicated:
∙ for the treatment of acute and chronic schizophrenic, psychoses, hallucinations and delusions.
∙ To alleviates affective symptoms (such as depression, guilt feelings, anxiety) associated with schizophrenia. |
| Product Name | SUNLENCA FILM-COATED TABLET 300MG,
SUNLENCA SOLUTION FOR INJECTION 463.5MG/1.5ML |
|---|
| Active Ingredient (Strength) | Lenacapavir Sodium eqv Lenacapavir(300mg),
Lenacapavir Sodium eqv Lenacapavir(463.5mg/1.5ml) |
| Application type | NDA-1/2: New chemical entity |
| Product Registrant | GILEAD SCIENCES SINGAPORE PTE. LTD. |
| Date of Approval | 27/02/2025 |
| Registration No. | SIN17188P,
SIN17189P |
Indications:
Sunlenca tablet, in combination with other antiretroviral(s), is indicated for the treatment of adults with multidrug resistant HIV-1 infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen, for oral loading prior to administration of long-acting lenacapavir injection (see sections 4.2 and 5.1).Sunlenca injection, in combination with other antiretroviral(s), is indicated for the treatment of adults with multidrug resistant HIV-1 infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen (see sections 4.2 and 5.1). |
Healthcare professional, Industry member, Therapeutic Products
Published:
New Drug Approvals