New drug approvals - March 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 NameALPHAGAN P OPHTHALMIC SOLUTION 0.1% W/V
Active Ingredient (Strength) Brimonidine tartrate(0.1% w/v)
Application type NDA-2
Product Registrant ABBVIE PTE. LTD.
Date of Approval 07/03/2025
Registration No. SIN17198P
Indications:
ALPHAGAN P is indicated for the lowering of intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

 

Product NameDEXTENZA OPHTHALMIC INSERT 0.4 MG
Active Ingredient (Strength) Dexamethasone (micronized)(0.4 mg)
Application type NDA-2
Product Registrant LABCORP DEVELOPMENT (ASIA) PTE. LTD.
Date of Approval 05/03/2025
Registration No. SIN17195P
Indications:
2.1 Ocular Inflammation and Pain Following Ophthalmic Surgery
DEXTENZA (dexamethasone ophthalmic insert) is a corticosteroid indicated for the treatment of ocular inflammation and pain following ophthalmic surgery (Refer to Section 12.1).

2.2 Itching Associated with Allergic Conjunctivitis
DEXTENZA (dexamethasone ophthalmic insert) is a corticosteroid indicated for the treatment of ocular itching associated with allergic conjunctivitis (Refer to Section 12.2).

 

Product NameFORLAX POWDER FOR ORAL SOLUTION 4G/SACHET
Active Ingredient (Strength) Macrogol 4000 (Polyethylene glycol 4000)(4.00g)
Application type NDA-2
Product Registrant DKSH SINGAPORE PTE. LTD.
Date of Approval 25/03/2025
Registration No. SIN17210P
Indications:
Forlax® 4 g is used for the treatment of constipation in children from 6 months to 8 years of age.

 

Product NameLIVTENCITY FILM-COATED TABLET 200MG
Active Ingredient (Strength) Maribavir(200mg)
Application type NDA-1
Product Registrant TAKEDA PHARMACEUTICALS (ASIA PACIFIC) PTE. LTD.
Date of Approval 18/03/2025
Registration No. SIN17208P
Indications:
Treatment of adults with post-transplant cytomegalovirus (CMV) infection/disease, who are refractory (with or without genotypic resistance) or intolerant to one or more prior therapies (see 4.3 CONTRAINDICATIONS, 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE and 5.1 PHARMACODYNAMIC PROPERTIES).

 

Product NameLOQTORZI CONCENTRATE FOR SOLUTION FOR INFUSION 240MG/6ML
Active Ingredient (Strength) Toripalimab(240mg/6mL)
Application type NDA-1
Product Registrant NYPRAX PHARMA PTE. LTD.
Date of Approval 26/03/2025
Registration No. SIN17212P

Indications:
LOQTORZI, in combination with cisplatin and gemcitabine, is indicated for the first-line treatment of adult patients with recurrent, not amenable to surgery or radiotherapy, or metastatic nasopharyngeal carcinoma.

*Evaluated as part of Project Orbis.

 

Product NameLORMALZI CONCENTRATE FOR SOLUTION FOR INFUSION 350MG/20ML
Active Ingredient (Strength) Donanemab(350mg/20mL)
Application type NDA-1
Product Registrant DKSH SINGAPORE PTE. LTD.
Date of Approval 11/03/2025
Registration No. SIN17201P

Indications:
Donanemab is indicated to slow disease progression in adult patients with Alzheimer’s disease (AD). Treatment with donanemab should be initiated in patients with evidence of amyloid beta pathology and either mild cognitive impairment or mild dementia.

Evaluated via ACCESS

 

Product NameNEMLUVIO POWDER AND SOLVENT FOR SOLUTION FOR INJECTION IN PRE-FILLED PEN 30MG,
NEMLUVIO POWDER AND SOLVENT FOR SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 30MG
Active Ingredient (Strength) Nemolizumab(30mg)
Application type NDA-1,
NDA-2
Product Registrant GALDERMA SINGAPORE PRIVATE LIMITED
Date of Approval 17/03/2025
Registration No. SIN17206P,
SIN17207P

Indications:
Nemluvio is indicated for the treatment of moderate-to-severe atopic dermatitis in combination with topical corticosteroids (TCS) and/or topical calcineurin inhibitors (TCI) in adult and adolescent patients ≥ 12 years old with body weight of at least 30 kg, who are inadequately controlled by topical therapies and are candidates for systemic therapy.

Nemluvio is indicated for the treatment of adults with moderate-to-severe prurigo nodularis who are candidates for systemic therapy.

Evaluated via ACCESS

 

Product NameVEOZA™ FILM-COATED TABLETS 45 MG
Active Ingredient (Strength) Fezolinetant(45.0mg)
Application type NDA-1
Product Registrant ASTELLAS PHARMA SINGAPORE PTE. LTD.
Date of Approval 05/03/2025
Registration No. SIN17196P
Indications:
VEOZA is indicated for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause (see section 5.1).

 

Product NameVYLOY™ POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 100MG/VIAL
Active Ingredient (Strength) Zolbetuximab(100mg/vial)
Application type NDA-1
Product Registrant ASTELLAS PHARMA SINGAPORE PTE. LTD.
Date of Approval 06/03/2025
Registration No. SIN17197P

Indications:
Vyloy, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are Claudin (CLDN) 18.2 positive (see section 5.1).

Evaluated via ACCESS


Healthcare professional, Industry member, Therapeutic Products
Published:

New Drug Approvals

12 Aug 2025