New drug indication approval - November 2025
For the most updated information related to registered therapeutic products, please refer to the Register of Therapeutic Products.
| Product Name | AKLIEF CREAM 50MCG/G |
| Active Ingredient (Strength) | Trifarotene(50 mcg/g) |
| Product Registrant | GALDERMA SINGAPORE PRIVATE LIMITED |
| Date of Approval | 10/11/2025 |
Indications:
Aklief is indicated for the topical treatment of Acne Vulgaris of the face and/or the trunk in patients from 12 years of age and older, when many comedones, papules and/or pustules are present. |
| Product Name | VOCABRIA FILM-COATED TABLETS 30MG,
VOCABRIA PROLONGED-RELEASE SUSPENSION FOR INJECTION 600 MG/3 ML,
VOCABRIA PROLONGED-RELEASE SUSPENSION FOR INJECTION 400 MG/ 2 ML |
| Active Ingredient (Strength) | Cabotegravir Sodium eqv Cabotegravir(30mg),
Cabotegravir(200mg/ml),
Cabotegravir(200 mg/ml) |
| Product Registrant | GLAXOSMITHKLINE PTE LTD |
| Date of Approval | 14/11/2025 |
Indications:
Film-coated Tablets:
VOCABRIA tablets are indicated in combination with rilpivirine tablets for short term (see Dosage and Administration) treatment of human immunodeficiency virus (HIV)-1 infection in adults and adolescents at least 12 years of age and weighing at least 35 kg, who are virologically suppressed (HIV-1 RNA of viral resistance to, and no prior virological failure with agents of the NNRTI and INI class:
- oral lead-in to assess tolerability of cabotegravir prior to administration of long
acting (LA) VOCABRIA injection.
- oral therapy for adults and adolescents who will miss planned dosing with VOCABRIA injection.
Suspension for Injection:
VOCABRIA injection is indicated in combination with rilpivirine injection for treatment of HIV-1 infection in adults and adolescents at least 12 years of age and weighing at least 35 kg, who are virologically suppressed (HIV-1 RNA < 50 copies/ml) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the NNRTI and INI class (see Clinical studies). |
| Product Name | KEYTRUDA SOLUTION FOR INFUSION 25MG/ML |
| Active Ingredient (Strength) | Pembrolizumab(25.0 mg/mL) |
| Product Registrant | MSD PHARMA (SINGAPORE) PTE. LTD. |
| Date of Approval | 04/11/2025 |
Indications:
KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of adult patients with unresectable non-epithelioid malignant pleural mesothelioma (MPM).
* Evaluated via Project ORBIS |
| Product Name | OZEMPIC 1MG/DOSE SOLUTION FOR INJECTION IN PRE-FILLED PEN 1.34MG/ML,
OZEMPIC 0.25MG, 0.5MG/DOSE SOLUTION FOR INJECTION IN PRE-FILLED PEN 1.34MG/ML |
| Active Ingredient (Strength) | Semaglutide(1.34mg/ml),
Semaglutide(1.34mg/ml) |
| Product Registrant | NOVO NORDISK PHARMA (SINGAPORE) PTE LTD |
| Date of Approval | 06/11/2025 |
Indications:
Ozempic® is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise to reduce the risk of sustained eGFR decline, end-stage kidney disease, and cardiovascular death in adults with type 2 diabetes mellitus and chronic kidney disease. |
| Product Name | DUPIXENT SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE 300 MG/2ML,
DUPIXENT SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE 200 MG/1.14ML |
| Active Ingredient (Strength) | Dupilumab(300 mg/2ml),
Dupilumab(200mg per 1.14mL) |
| Product Registrant | SANOFI-AVENTIS SINGAPORE PTE. LTD. |
| Date of Approval | 20/11/2025 |
Indications:
DUPIXENT is indicated for the treatment of chronic spontaneous urticaria (CSU) in patients aged 12 years and older with inadequate response to H1 antihistamine treatment and who are naive to anti-IgE therapy for CSU.
* Evaluated via Access work sharing |
Healthcare professional, Industry member, Therapeutic Products
Published:
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New Drug Indication Approvals