New Drug Approvals

New drug approvals - December 2025

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Product type

Therapeutic Products

12 February 2025

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New drug approvals - December 2024

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

Drug details

Product Name	CONJUPRI TABLETS 5MG, CONJUPRI TABLETS 2.5MG
Active Ingredient (Strength)	Levamlodipine maleate eqv. levamlodipine(5.00 mg), Levamlodipine maleate eqv. levamlodipine(2.50 mg)
Application type	NDA-1: New chemical entity NDA-3: New strength
Product Registrant	LOTUS INTERNATIONAL PTE. LTD.
Date of Approval	26/12/2024
Registration No.	SIN17153P, SIN17154P
Indications: Hypertension Levamlodipine is indicated for the first-line treatment of hypertension and can be used as the sole agent to control blood pressure in the majority of patients. Patients not adequately controlled on a single antihypertensive agent may benefit from the addition of levamlodipine, which has been used in combination with a thiazide diuretic, alpha blockers, beta adrenoceptor blocking agent, or an angiotensin-converting enzyme (ACE) inhibitor.

Drug details

Product Name	ELREXFIO SOLUTION FOR INJECTION 44 MG/1.1 ML, ELREXFIO SOLUTION FOR INJECTION 76 MG/1.9 ML
Active Ingredient (Strength)	Elranatamab(44 mg/1.1 ml), Elranatamab(76 mg/1.9 ml)
Application type	NDA-1: New biological entity NDA-3: New strength
Product Registrant	PFIZER PRIVATE LIMITED
Date of Approval	31/12/2024
Registration No.	SIN17155P, SIN17156P
Indications: ELREXFIO is a B-cell maturation antigen (BCMA)-directed and CD3-directed bispecific antibody indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. *Evaluated as part of Project Orbis.

Drug details

Product Name	NUVAXOVID DISPERSION FOR INJECTION COVID-19 VACCINE 5 MCG/DOSE (RECOMBINANT, ADJUVANTED) IN SDV
Active Ingredient (Strength)	SARS-CoV-2 recombinant spike protein (Omicron JN.1)(5 mcg/dose)
Application type	NDA-2: New presentation
Product Registrant	PHARMENG TECHNOLOGY PTE. LTD.
Date of Approval	16/12/2024
Registration No.	SIN17148P
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.

Drug details

Product Name	TAVNEOS HARD CAPSULE 10MG
Active Ingredient (Strength)	Avacopan(10mg)
Application type	NDA-1: New chemical entity
Product Registrant	VIFOR PHARMA ASIA PACIFIC PTE. LTD.
Date of Approval	24/12/2024
Registration No.	SIN17150P
Indications: Tavneos is indicated as an adjunctive treatment of adult patients with severe, active anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA] or microscopic polyangiitis [MPA]) in combination with standard therapy, including glucocorticoids.

Drug details

Product Name	VOYDEYA FILM-COATED TABLET 100 MG + 100 MG, VOYDEYA FILM-COATED TABLET 100 MG + 50 MG
Active Ingredient (Strength)	Danicopan(100mg), Danicopan(50mg)
Application type	NDA-1: New chemical entity NDA-3: New strength
Product Registrant	ASTRAZENECA SINGAPORE PTE LTD
Date of Approval	26/12/2024
Registration No.	SIN17151P, SIN17152P
Indications: VOYDEYA is indicated as an add-on to ravulizumab or eculizumab for the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) who have residual haemolytic anaemia.

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