New drug approvals - November 2025

 

  • Please click here for a list of summary reports of benefit-risk assessments.
  • Please click here for description of application types.

For the most updated information related to registered therapeutic products, please refer to the Register of Therapeutic Products.

Product NameADLARITY TRANSDERMAL SYSTEM 5 MG/24 HOURS,
ADLARITY TRANSDERMAL SYSTEM 10 MG/24 HOURS
Active Ingredient (Strength) Donepezil hydrochloride eqv donepezil(5 mg/24 hours),
Donepezil hydrochloride eqv donepezil(10 mg/24 hours)
Application type NDA-2,
NDA-3
Product Registrant LOTUS INTERNATIONAL PTE. LTD.
Date of Approval 03/11/2025
Registration No. SIN17381P,
SIN17382P
Indications:
ADLARITY is indicated for the symptomatic treatment of mild, moderate, and severe dementia of the Alzheimer’s type.

 

Product NameAPROKAM POWDER FOR SOLUTION FOR INJECTION 50MG/VIAL
Active Ingredient (Strength) Cefuroxime Sodium eqv Cefuroxime(50mg/ vial)
Application type NDA-2
Product Registrant CELESTE (S) PTE LTD
Date of Approval 12/11/2025
Registration No. SIN17391P
Indications:
Antibiotic prophylaxis of postoperative endophthalmitis after cataract surgery (see section 5.1).

Consideration should be given to official guidance on the appropriate use of antibacterial agents, including guidance on the antibiotic prophylaxis on eye surgery.

 

Product NameEKTERLY FILM-COATED TABLETS 300 MG
Active Ingredient (Strength) Sebetralstat(300.0 mg)
Application type NDA-1
Product Registrant PHARMA TO MARKET PTE. LTD.
Date of Approval 12/11/2025
Registration No. SIN17392P
Indications:
Ekterly is indicated for the treatment of hereditary angioedema (HAE) attacks in adults and adolescents aged 12 years and older.

* Evaluated via Access work sharing

 

Product NameELAHERE CONCENTRATE FOR SOLUTION FOR INFUSION 100MG/20ML
Active Ingredient (Strength) Mirvetuximab soravtansine(100mg/20mL)
Application type NDA-1
Product Registrant ABBVIE PTE. LTD.
Date of Approval 21/11/2025
Registration No. SIN17405P
Indications:
ELAHERE as monotherapy is indicated for the treatment of adult patients with folate receptor-alpha (FRα) positive, platinum-resistant high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens.

 

Product NameITOVEBI FILM COATED TABLETS 3MG,
ITOVEBI FILM COATED TABLETS 9 MG
Active Ingredient (Strength) Inavolisib(3mg),
Inavolisib(9mg)
Application type NDA-1,
NDA-3
Product Registrant ROCHE SINGAPORE PTE. LTD.
Date of Approval 20/11/2025
Registration No. SIN17403P,
SIN17404P
Indications:
Itovebi, in combination with palbociclib and fulvestrant, is indicated for the treatment of adult patients with PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, following recurrence on or within 12 months of completing adjuvant endocrine therapy.

* Evaluated via Project ORBIS

 

Product NameLIVAZEBE FILM-COATED TABLETS 2 MG/10 MG,
LIVAZEBE FILM-COATED TABLETS 4 MG/10 MG
Active Ingredient (Strength) Ezetimibe(10.0mg),Pitavastatin Calcium Hydrate eqv Pitavastatin Calcium(2mg),
Ezetimibe(10.0mg),Pitavastatin Calcium Hydrate eqv Pitavastatin Calcium(4mg)
Application type NDA-2,
NDA-3
Product Registrant DKSH SINGAPORE PTE. LTD.
Date of Approval 13/11/2025
Registration No. SIN17394P,
SIN17395P
Indications:
Hypercholesterolemia/ Familial Hypercholesterolemia
LIVAZEBE is indicated as adjunct therapy to diet for treatment of primary hypercholesterolaemia including heterozygous familial.
LIVAZEBE is indicated as adjunct therapy to LDL apheresis for treatment of homozygous familial  hypercholesterolaemia or when such therapies are not feasible.

 

Product NameLUTETIUM (177LU) CHLORIDE RADIOPHARMACEUTICAL PRECURSOR SOLUTION 51.8 GBQ/ML
Active Ingredient (Strength) Lutetium (177Lu) chloride(51.8 GBq/mL)
Application type NDA-2
Product Registrant TRANSMEDIC PTE LTD
Date of Approval 03/11/2025
Registration No. SIN17383P
Indications:
Lutetium (177Lu) chloride is a radiopharmaceutical precursor, and it is not intended for direct use in patients. It is to be used only for the radiolabelling of carrier molecules that have been specifically developed and authorised for radiolabelling with lutetium (177Lu) chloride.

 

Product NameNUVAXOVID DISPERSION FOR INJECTION COVID19 VACCINE 5MCG/DOSE (RECOMBINANT, ADJUVANTED) IN PFS
Active Ingredient (Strength) SARS-CoV-2 recombinant spike protein (Omicron JN.1)(5 mcg/0.5ml)
Application type NDA-2
Product Registrant PE PHARMA PTE LTD
Date of Approval 04/11/2025
Registration No. SIN17384P
Indications:
Nuvaxovid JN.1 is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older. The use of this vaccine should be in accordance with official recommendations.

 

Product NameOCREVUS SOLUTION FOR INJECTION 920MG/23ML
Active Ingredient (Strength) Ocrelizumab(920 mg/23 mL)
Application type NDA-2
Product Registrant ROCHE SINGAPORE PTE. LTD.
Date of Approval 11/11/2025
Registration No. SIN17390P
Indications:
Ocrevus is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features, to reduce the frequency of clinical relapses and delay the progression of physical disability.
Ocrevus is indicated for the treatment of adult patients with early primary progressive multiple sclerosis (PPMS) with imaging features characteristic of inflammatory activity to delay progression of physical disability.

 

Product NameOSENVELT® SOLUTION FOR INJECTION 120MG/1.7ML
Active Ingredient (Strength) Denosumab(120 mg/1.7 ml)
Application type NDA-2: Biosimilar
Product Registrant CELLTRION HEALTHCARE SINGAPORE PRIVATE LIMITED
Date of Approval 07/11/2025
Registration No. SIN17388P
Indications:
Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in patients with multiple myeloma and in patients with bone metastases from solid tumours.
Treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity.

 

Product NameSTOBOCLO® SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 60MG/ML
Active Ingredient (Strength) Denosumab(60 mg/ml)
Application type NDA-2: Biosimilar
Product Registrant CELLTRION HEALTHCARE SINGAPORE PRIVATE LIMITED
Date of Approval 07/11/2025
Registration No. SIN17387P

Indications:
1.1  Treatment of Postmenopausal Women with Osteoporosis at High Risk for Fracture
Stoboclo is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, denosumab reduces the incidence of vertebral, nonvertebral, and hip fractures [see Clinical Studies (14.1)].

1.2  Treatment to Increase Bone Mass in Men with Osteoporosis
Stoboclo is indicated for treatment to increase bone mass in men with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy [see Clinical Studies (14.2)].

1.3  Treatment of Glucocorticoid-Induced Osteoporosis
Stoboclo is indicated for the treatment of glucocorticoid-induced osteoporosis in men and women at high risk of fracture who are either initiating or continuing systemic glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and expected to remain on glucocorticoids for at least 6 months. High risk of fracture is defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy [see Clinical Studies (14.3)].

1.4  Treatment of Bone Loss in Men Receiving Androgen Deprivation Therapy for Prostate Cancer
Stoboclo is indicated as a treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer. In these patients denosumab also reduced the incidence of vertebral fractures [see Clinical Studies (14.4)].

1.5  Treatment of Bone Loss in Women Receiving Adjuvant Aromatase Inhibitor Therapy for Breast Cancer
Stoboclo is indicated as a treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer [see Clinical Studies (14.5)].

     

 

Product NameVYVGART CONCENTRATE FOR SOLUTION FOR INFUSION 20 MG/ML
Active Ingredient (Strength) Efgartigimod alfa(20mg/ml)
Application type NDA-1
Product Registrant KREIVO MANAGEMENT CONSULTANCY PTE LTD
Date of Approval 20/11/2025
Registration No. SIN17402P
Indications:
Vyvgart is indicated as an add-on to standard therapy for the treatment of adult patients with generalised Myasthenia Gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive.

 


Healthcare professional, Industry member, Therapeutic Products
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New Drug Approvals

31 Dec 2025