New drug approvals - June 2025

 

• Please click here for a list of summary reports of benefit-risk assessments.
• Please click here for description of application types.

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

Product Name	GLAALPHA COMBINATION OPHTHALMIC SOLUTION
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.

 

Product Name	HYQVIA SOLUTION FOR INFUSION 100MG/ML
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.

 

Product Name	MOUNJARO KWIKPEN SOLUTION FOR INJECTION IN PRE-FILLED PEN 2.5MG/0.6ML, MOUNJARO KWIKPEN SOLUTION FOR INJECTION IN PRE-FILLED PEN 15MG/0.6ML, MOUNJARO KWIKPEN SOLUTION FOR INJECTION IN PRE-FILLED PEN 5MG/0.6ML, MOUNJARO KWIKPEN SOLUTION FOR INJECTION IN PRE-FILLED PEN 7.5MG/0.6ML, MOUNJARO KWIKPEN SOLUTION FOR INJECTION IN PRE-FILLED PEN 10MG/0.6ML, MOUNJARO KWIKPEN SOLUTION FOR INJECTION IN PRE-FILLED PEN 12.5MG/0.6ML
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)

 

Product Name	POTELIGEO CONCENTRATE FOR SOLUTION FOR INFUSION 20MG/5ML
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.

 

Published: 14 Aug 2025

New Drug Approvals