New drug approvals - November 2025

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.

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.

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

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.

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

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.

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.

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.

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.

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.

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)].

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.