New Drug Approvals

New drug approvals - May 2024

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Healthcare professional

Industry member

Product type

Therapeutic Products

2 July 2024

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

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Product Name	AREXVY POWDER AND SUSPENSION FOR SUSPENSION FOR INJECTION 120MCG/0.5ML
Active Ingredient (Strength)	RSVPreF3 antigen(120mcg/0.5mL)
Application type	NDA-1: New biological entity
Product Registrant	GLAXOSMITHKLINE PTE LTD
Date of Approval	10/05/2024
Registration No.	SIN17008P
Indications: Arexvy is indicated for active immunisation for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus in adults 60 years of age and older. Consideration should be given to official vaccine recommendations on the appropriate use.

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Product Name	BESREMI SOLUTION FOR INJECTION IN PREFILLED SYRINGE 500 MICROGRAMS/ML
Active Ingredient (Strength)	Ropeginterferon alfa-2b(500 µg/mL)
Application type	NDA-1: New biological entity
Product Registrant	PHARMAESSENTIA SINGAPORE PTE. LTD
Date of Approval	29/05/2024
Registration No.	SIN17014P
Indications: Besremi is indicated as monotherapy in adults for the treatment of polycythemia vera (see Section 14 Clinical Studies).

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Product Name	COMIRNATY, DISPERSION FOR INJECTION, 10 MICROGRAMS/DOSE (SINGLE-DOSE VIAL), COMIRNATY, DISPERSION FOR INJECTION, 30 MICROGRAMS/DOSE (SINGLE-DOSE VIAL)
Active Ingredient (Strength)	Raxtozinameran(10 μg/dose), Raxtozinameran(30 mcg/dose)
Application type	NDA-2: New presentation
Product Registrant	BIONTECH PHARMACEUTICALS ASIA PACIFIC PTE. LTD.
Date of Approval	31/05/2024
Registration No.	SIN17017P, SIN17016P
Indications: COMIRNATY is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 6 months of age and older. The use of this vaccine should be in accordance with official recommendations.

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Product Name	INHIXA SOLUTION FOR INJECTION 6000 ANTI-XA IU (60MG)/0.6ML, INHIXA SOLUTION FOR INJECTION 4000 ANTI-XA IU (40MG)/0.4ML, INHIXA SOLUTION FOR INJECTION 2000 ANTI-XA IU (20MG)/0.2ML
Active Ingredient (Strength)	Enoxaparin Sodium(6000 IU (60 MG)/0.6 ML), Enoxaparin Sodium(4000 IU (40 MG)/0.4 ML), Enoxaparin Sodium(2000 IU (20 MG)/0.2 ML)
Application type	NDA-3: New strength
Product Registrant	PHARMAZEN MEDICALS PTE LTD
Date of Approval	07/05/2024
Registration No.	SIN16997P, SIN16998P, SIN16999P
Indications: Inhixa is indicated in adults for: · Prophylaxis of venous thromboembolic disease (prevention of blood clot formation in the veins), in particular those which may be associated with orthopedic or general surgery. · Prophylaxis of venous thromboembolic disease in medical patients bedridden due to acute illnesses. · Treatment of established deep vein thrombosis. · Prevention of thrombus formation in extracorporeal circulation during haemodialysis. · Treatment of unstable angina and non-Q-wave myocardial infarction, administered concurrently with aspirin. · Treatment of acute ST-segment Elevation Myocardial Infarction (STEMI), in combination with a thrombolytic agent, in patients to be managed medically or with subsequent Percutaneous Coronary Intervention (PCI).

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Product Name	LUNSUMIO CONCENTRATE FOR SOLUTION FOR INFUSION 1MG/ML, LUNSUMIO CONCENTRATE FOR SOLUTION FOR INFUSION 30MG/30ML
Active Ingredient (Strength)	Mosunetuzumab(1 mg/ml), Mosunetuzumab(30 mg/30 ml)
Application type	NDA-1: New biological entity NDA-3: new strengths
Product Registrant	ROCHE SINGAPORE PTE. LTD.
Date of Approval	08/05/2024
Registration No.	SIN17001P, SIN17002P
Indications: Lunsumio as monotherapy is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least two prior systemic therapies.

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Product Name	VELSIPITY FILM-COATED TABLET 2 MG
Active Ingredient (Strength)	Etrasimod L-arginine eqv Etrasimod(2 mg)
Application type	NDA-1: New chemical entity
Product Registrant	PFIZER PRIVATE LIMITED
Date of Approval	30/05/2024
Registration No.	SIN17015P
Indications: VELSIPITY is indicated for the treatment of moderately to severely active ulcerative colitis (UC) in adult patients who have had an inadequate response to, loss of response to, or intolerance to at least 1 therapy for ulcerative colitis. *Evaluated via ACCESS

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