New Drug Approvals

New drug approvals - March 2025

Audiences

Healthcare professional

Industry member

Product type

Therapeutic Products

25 April 2025

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

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

Drug caption

Product Name	ALPHAGAN 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.

Drug caption

Product Name	DEXTENZA 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).

Drug caption

Product Name	FORLAX 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.

Drug caption

Product Name	LIVTENCITY 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).

Drug caption

Product Name	LOQTORZI 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.

Drug caption

Product Name	LORMALZI 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

Drug caption

Product Name	NEMLUVIO 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

Drug caption

Product Name	VEOZA™ 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).

Drug caption

Product Name	VYLOY™ 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

Government officials will never ask you to transfer money or disclose bank log-in details over a phone call.