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 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. |
| 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). |
| 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. |
| 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). |
| 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. |
| 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 |
| 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 |
| 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). |
| 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 |
Healthcare professional, Industry member, Therapeutic Products
Published:
New Drug Approvals