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Health Sciences Authority
New Drug Indication Approvals

New drug indication approval - January 2025

Audiences

Healthcare professional

Industry member

Product type

Therapeutic Products

17 February 2025

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

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

Drug caption

Product Name

BALVERSA FILM-COATED TABLETS 3MG,
BALVERSA FILM-COATED TABLETS 4MG,
BALVERSA FILM-COATED TABLETS 5MG

Active Ingredient (Strength)

Erdafitinib(3.00 mg),
Erdafitinib(4.00 mg),
Erdafitinib(5.00 mg)

Product Registrant

JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD

Date of Approval

03/01/2025

Indications:
BALVERSA™ is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible fibroblast growth factor receptor (FGFR) 3 genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy (see Pharmacodynamic Effects - Clinical studies).
Select patients for therapy based on a companion diagnostic for Balversa™.

Limitations of Use
BALVERSA™ is not recommended for the treatment of patients who are eligible for and have not received prior programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor therapy.

Drug caption

Product Name

PERTAGEN® SUSPENSION FOR INJECTION 0.5 ML/DOSE

Active Ingredient (Strength)

Filamentous Haemagglutinin (FHA)(5 ug/0.5 ml),Recombinant Pertussis Toxin (rPT)(5 ug/0.5 ml)

Product Registrant

NOVEM HEALTHCARE PTE LTD

Date of Approval

16/01/2025

Indications:
Pertagen® is indicated for active booster immunization against pertussis in individuals from the age of 3 years onwards.
Pertagen® is indicated for maternal immunization in pregnant women for the prevention of pertussis in infants too young to be vaccinated.
Pertagen® should be used in accordance with official recommendations for booster vaccination and maternal immunization against pertussis only.

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