New drug approvals - March 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 | COLUMVI CONCENTRATE FOR SOLUTION FOR INFUSION 1MG/ML |
| Active Ingredient (Strength) | Glofitamab(1 mg/ml) |
| Application type | NDA-1: New biological entity |
| Product Registrant | ROCHE SINGAPORE PTE. LTD. |
| Date of Approval | 05/03/2024 |
| Registration No. | SIN16968P |
Indications:
Columvi is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. (See 3.1.2 Clinical / Efficacy Studies) *Evaluated as part of Project Orbis |
| Product Name | JYSELECA FILM-COATED TABLET 100MG,
JYSELECA FILM-COATED TABLET 200MG |
| Active Ingredient (Strength) | Filgotinib maleate eqv filgotinib(100 mg),
Filgotinib maleate eqv filgotinib(200 mg) |
| Application type | NDA-1: New chemical entity
NDA-3: New strength |
| Product Registrant | EISAI (SINGAPORE) PTE. LTD. |
| Date of Approval | 27/03/2024 |
| Registration No. | SIN16980P,
SIN16981P |
Indications:
Jyseleca is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). Jyseleca may be used as monotherapy or in combination with methotrexate (MTX).
Jyseleca is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic agent. |
| Product Name | NEFEGAN MODIFIED RELEASE CAPSULE 4MG |
| Active Ingredient (Strength) | Budesonide(4.00 mg) |
| Application type | NDA-2: New formulation |
| Product Registrant | EVEREST MEDICINES (SINGAPORE) PTE. LTD. |
| Date of Approval | 19/03/2024 |
| Registration No. | SIN16972P |
Indications:
NEFEGAN is indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/g. |
| Product Name | SKIIP NICOTINE MINI LOZENGE 4 MG (MINT) |
| Active Ingredient (Strength) | Nicotine Polacrilex eqv to Nicotine(4.00 mg) |
| Application type | NDA-3: New strength |
| Product Registrant | RUBICON RESEARCH PRIVATE LIMITED |
| Date of Approval | 13/03/2024 |
| Registration No. | SIN16971P |
Indications:
The lozenge can reduce your desire to smoke and help improve your willpower to resist smoking by providing some of the nicotine previously inhaled. Nicotine Mini Lozenge is best suited for those with high nicotine dependency. |
Healthcare professional, Industry member, Therapeutic Products
Published:
New Drug Approvals