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Health Sciences Authority
New Drug Approvals

New drug approvals - February 2025

Audiences

Healthcare professional

Industry member

Product type

Therapeutic Products

14 March 2025

This article has been migrated from an earlier version of the site and may display formatting inconsistencies.

  • 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.

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).

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