New drug approvals - June 2025

Active Ingredient (Strength)

Brimonidine tartrate(1.0mg/mL),Ripasudil hydrochloride hydrate eqv. Ripasudil(4.0 mg/mL)

Application type

NDA-2

Product Registrant

DKSH SINGAPORE PTE. LTD.

Date of Approval

25/06/2025

Registration No.

SIN17265P

Indications:
GLAALPHA is indicated for the lowering of intraocular pressure in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to monotherapy.

Active Ingredient (Strength)

(IG 10%) Human normal immunoglobulin(100mg/ml)

Application type

NDA-2

Product Registrant

TAKEDA PHARMACEUTICALS (ASIA PACIFIC) PTE. LTD.

Date of Approval

10/06/2025

Registration No.

SIN17253P

Indications:
Replacement therapy in adults, children and adolescents (0 to 18 years) in:
• Primary immunodeficiency syndromes (PID) with impaired antibody production (see section 4.4).
• Secondary immunodeficiencies (SID) in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure (PSAF)* or serum IgG level of < 4 g/L.
*PSAF = failure to mount at least a 2-fold rise in IgG antibody titre to pneumococcal polysaccharide and polypeptide antigen vaccines.
Immunomodulatory therapy in adults, children and adolescents (0 to 18 years) in:
• Chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy after stabilization with IVIg.

Active Ingredient (Strength)

Tirzepatide(2.5MG/0.6ML),
Tirzepatide(15MG/0.6ML),
Tirzepatide(5MG/0.6ML),
Tirzepatide(7.5mg/0.6mL),
Tirzepatide(10MG/0.6ML),
Tirzepatide(12.5MG/0.6ML)

Application type

NDA-2,
NDA-3,
NDA-3,
NDA-3,
NDA-3,
NDA-3

Product Registrant

DKSH SINGAPORE PTE. LTD.

Date of Approval

18/06/2025

Registration No.

SIN17257P,
SIN17258P,
SIN17259P,
SIN17260P,
SIN17261P,
SIN17262P

Indications:
Type 2 diabetes mellitus
Mounjaro is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise
• as monotherapy when metformin is considered inappropriate due to intolerance or contraindications
• in addition to other medicinal products for the treatment of diabetes.
For study results with respect to combinations, effects on glycaemic control and the populations studied, see sections 4.4, 4.5 and 5.1.

Weight management
Mounjaro is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management, including weight loss and weight maintenance, in adults with an initial Body Mass Index (BMI) of
• ≥ 30 kg/m2 (obesity) or
• ≥ 27 kg/m2 to < 30 kg/m2 (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidaemia, obstructive sleep apnoea, cardiovascular disease, prediabetes, or type 2 diabetes mellitus)

Active Ingredient (Strength)

Mogamulizumab(20 mg/5mL)

Application type

NDA-1

Product Registrant

KYOWA KIRIN ASIA PACIFIC PTE. LTD.

Date of Approval

09/06/2025

Registration No.

SIN17252P

Indications:
POTELIGEO is indicated for the treatment of adult patients with mycosis fungoides (MF) or Sézary syndrome (SS) who have received at least one prior systemic therapy.