New Drug Approvals

New drug approvals - February 2025

14 March 2025

Audiences

Healthcare professional

Industry member

Product-type

Therapeutic Products

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Please click here (opens in new tab) 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.

Drug caption

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.

Drug caption

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

Drug caption

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.

Drug caption

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).