New drug approvals - December 2024
- Please click here for a list of summary reports of benefit-risk assessments.
For the most updated information related to registered therapeutic products, please refer to the Register of Therapeutic Products.
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Healthcare professional, Industry member, Therapeutic Products
Published:
New Drug Approvals