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Health Sciences Authority
New Drug Approvals

New drug approvals - March 2024

Audiences

Healthcare professional

Industry member

Product type

Therapeutic Products

7 May 2024

This article has been migrated from an earlier version of the site and may display formatting inconsistencies.

  • 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.

Table caption

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

Table caption

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.

Table caption

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.

Table caption

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.

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